Trial Outcomes & Findings for Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (NCT NCT04390763)

Last Updated: 2025-10-16

Results Overview

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 where the relationship to study treatment cannot be ruled out and is not clearly related solely to disease, disease progression, inter-current illness or concomitant medications, which occurs within the DLT evaluation period. The DLT evaluation period is the first 28 days of treatment with NIS793 with spartalizumab in combination with gemcitabine/nab-paclitaxel. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

164 participants

Primary outcome timeframe

First cycle of treatment (28 days)

Results posted on

2025-10-16

Participant Flow

Participants took part in 31 investigative sites in 14 countries.

The screening period began once patients had signed the study informed consent. Screening evaluations had to be completed within 21 days prior to the first dose of study treatment (≤ 28 days for baseline radiological assessments). After screening, the treatment period started on Cycle 1 Day 1.

Participant milestones

Participant milestones
Measure	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the safety run-in part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Safety run-in Part STARTED	11	0	0	0
Safety run-in Part Safety Set 1	11	0	0	0
Safety run-in Part COMPLETED	0	0	0	0
Safety run-in Part NOT COMPLETED	11	0	0	0
Randomized Part STARTED	0	50	51	52
Randomized Part Full Analysis Set (FAS)	0	50	51	52
Randomized Part Safety Set 2	0	46	49	45
Randomized Part COMPLETED	0	0	0	0
Randomized Part NOT COMPLETED	0	50	51	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the safety run-in part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Safety run-in Part Adverse Event	4	0	0	0
Safety run-in Part Physician Decision	1	0	0	0
Safety run-in Part Progressive Disease	6	0	0	0
Randomized Part Adverse Event	0	11	5	5
Randomized Part Death	0	3	4	2
Randomized Part Physician Decision	0	2	2	9
Randomized Part Progressive Disease	0	24	31	23
Randomized Part Study terminated by sponsor	0	1	0	0
Randomized Part Participant Decision	0	5	7	6
Randomized Part Not treated	0	4	2	7

Baseline Characteristics

Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=11 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the safety run-in part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=50 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=51 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel n=52 Participants Standard of care chemotherapy in the randomized part	Total n=164 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 8.77 • n=5 Participants	64.3 years STANDARD_DEVIATION 10.91 • n=7 Participants	64.2 years STANDARD_DEVIATION 9.90 • n=5 Participants	64.8 years STANDARD_DEVIATION 8.25 • n=4 Participants	64.4 years STANDARD_DEVIATION 9.59 • n=21 Participants
Age, Customized 18 - <65 years	5 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	23 Participants n=4 Participants	71 Participants n=21 Participants
Age, Customized 65 - <85 years	6 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	29 Participants n=4 Participants	93 Participants n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	67 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants	32 Participants n=4 Participants	97 Participants n=21 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	39 Participants n=7 Participants	35 Participants n=5 Participants	33 Participants n=4 Participants	116 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	41 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: First cycle of treatment (28 days)

Population: Dose-Determining Set (DDS) including all participants in the Safety run-in part who met the minimum exposure criterion defined in the protocol and had sufficient safety evaluations after 4 weeks of treatment or experienced a DLT during the first 4 weeks of treatment.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=6 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs) Any DLT	—	1 Participants	—	—
Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs) Colitis	—	1 Participants	—	—

PRIMARY outcome

Timeframe: Up to approximately 0.8 years

Population: Safety set 1

Number of participants with AEs (any adverse events regardless of seriousness) and serious adverse events (SAEs), including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For CTCAE v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of any study treatment up to 30 days after the date of the last actual administration of any study drug.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=11 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period AEs	—	11 Participants	—	—
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related AEs	—	11 Participants	—	—
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period AEs with grade>=3	—	11 Participants	—	—
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related AEs with grade>=3	—	8 Participants	—	—
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period SAEs	—	8 Participants	—	—
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related SAEs	—	3 Participants	—	—
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period Fatal SAEs	—	1 Participants	—	—
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related fatal SAEs	—	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to approximately 0.7 years

Population: Safety set 1

Number of participants with at least one dose reduction and at least one dose interruption of study drugs. Dose adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule. No dose reductions were allowed for NIS793 and spartalizumab beyond the first 28 days period of Safety run-in part.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=11 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel NIS793: At least one dose reduction or interruption	—	5 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel NIS793: At least one dose reduction	—	0 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel NIS793: At least one dose interruption	—	5 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Spartalizumab: At least one dose reduction or interruption	—	3 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Spartalizumab: At least one dose reduction	—	0 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Spartalizumab: At least one dose interruption	—	3 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Gemcitabine: At least one dose reduction or interruption	—	9 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Gemcitabine: At least one dose reduction	—	2 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Gemcitabine: At least one dose interruption	—	9 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Nab-paclitaxel: At least one dose reduction or interruption	—	9 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Nab-paclitaxel: At least one dose reduction	—	3 Participants	—	—
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Nab-paclitaxel: At least one dose interruption	—	9 Participants	—	—

PRIMARY outcome

Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days.

Population: Patients in the Safety set 1 who received NIS793 or spartalizumab at each reported treatment cycle.

Dose intensity of NIS973 and spartalizumab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and multiplied by 28 days. Dose adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=11 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab NIS793 - cycle 3	—	4200.0 mg per cycle Standard Deviation 0.00	—	—
Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab Spartalizumab - cycle 1	—	400.0 mg per cycle Standard Deviation 0.00	—	—
Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab Spartalizumab - cycle 3	—	400.0 mg per cycle Standard Deviation 0.00	—	—
Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab NIS793 - cycle 1	—	3627.3 mg per cycle Standard Deviation 980.91	—	—

PRIMARY outcome

Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days.

Population: Patients in the Safety set 1 who received gemcitabine or nab-paclitaxel at each reported treatment cycle.

Dose intensity of gemcitabine and nab-paclitaxel was calculated as cumulative actual dose in milligrams/m\^2 divided by duration of exposure in days and multiplied by 28 days.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=11 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Gemcitabine - cycle 1	—	2425.4 mg per m^2 per cycle Standard Deviation 698.27	—	—
Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Gemcitabine - cycle 3	—	2619.1 mg per m^2 per cycle Standard Deviation 508.19	—	—
Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Nab-paclitaxel - cycle 1	—	303.3 mg per m^2 per cycle Standard Deviation 87.18	—	—
Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Nab-paclitaxel - cycle 3	—	327.6 mg per m^2 per cycle Standard Deviation 63.65	—	—

PRIMARY outcome

Timeframe: Up to approximately 2 years. Risk changing timepoint=approximately 0.3 years.

Population: Full Analysis Set (FAS)

PFS was based on local review of tumor assessments, using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. If a subject had not had an event, PFS was censored at the date of last adequate tumor assessment. PFS was estimated using a Bayesian model. For each comparison (arm 1 versus arm 3 and arm 2 versus arm 3), PFS was modeled using a two-piece hazard model, with specifying hazard rates before and after the possible delayed effect for arms 1 and 2 and constant hazard rate for arm 3. Results in the table as expressed as estimated posterior median hazard rate and one-sided 90% credible interval.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=52 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=50 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=51 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Bayesian Model Hazard rate before the risk changing timepoint	2.09 events (progression, death) per year Interval 0.0 to 2.53	2.54 events (progression, death) per year Interval 0.0 to 3.34	1.23 events (progression, death) per year Interval 0.0 to 1.79	—
Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Bayesian Model Hazard rate after the risk changing timepoint	2.09 events (progression, death) per year Interval 0.0 to 2.53	1.46 events (progression, death) per year Interval 0.0 to 2.06	2.94 events (progression, death) per year Interval 0.0 to 3.86	—

PRIMARY outcome

Timeframe: Up to approximately 2 years

Population: Full Analysis Set (FAS)

PFS was based on local review of tumor assessments, using RECIST 1.1 criteria. PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. If a subject had not had an event, PFS was censored at the date of last adequate tumor assessment. PFS was analyzed based on the Kaplan-Meier curves and the Cox model.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=52 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=50 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=51 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Kaplan-Meier Curves and Cox Model	4.37 months Interval 3.55 to 7.2	3.91 months Interval 3.06 to 6.93	5.52 months Interval 3.94 to 7.29	—

SECONDARY outcome

Timeframe: Up to approximately 1.8 years

Population: Safety set 2

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=45 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=46 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=49 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period AEs	43 Participants	45 Participants	49 Participants	—
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related AEs	38 Participants	45 Participants	45 Participants	—
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period AEs with grade>=3	35 Participants	42 Participants	42 Participants	—
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related AEs with grade>=3	24 Participants	34 Participants	37 Participants	—
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period SAEs	26 Participants	32 Participants	26 Participants	—
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related SAEs	12 Participants	19 Participants	12 Participants	—
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period Fatal SAEs	4 Participants	3 Participants	1 Participants	—
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period Treatment-related fatal SAEs	0 Participants	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 1.7 years

Population: Safety set 2

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=45 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=46 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=49 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel NIS793: At least one dose reduction or interruption	—	35 Participants	31 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel NIS793: At least one dose reduction	—	0 Participants	0 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel NIS793: At least one dose interruption	—	35 Participants	31 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Spartalizumab: At least one dose reduction or interruption	—	21 Participants	—	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Spartalizumab: At least one dose reduction	—	0 Participants	—	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Spartalizumab: At least one dose interruption	—	21 Participants	—	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Gemcitabine: At least one dose reduction or interruption	32 Participants	38 Participants	41 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Gemcitabine: At least one dose reduction	19 Participants	25 Participants	23 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Gemcitabine: At least one dose interruption	29 Participants	35 Participants	36 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Nab-paclitaxel: At least one dose reduction or interruption	34 Participants	39 Participants	43 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Nab-paclitaxel: At least one dose reduction	19 Participants	26 Participants	27 Participants	—
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel Nab-paclitaxel: At least one dose interruption	32 Participants	34 Participants	37 Participants	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days

Population: Patients in the Safety set 2 who received NIS793 or spartalizumab at each reported treatment cycle.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=46 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=49 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Dose Intensity of NIS973 and Spartalizumab NIS793 - cycle 1	—	3515.2 mg per cycle Standard Deviation 995.32	3857.1 mg per cycle Standard Deviation 784.22	—
Randomized Part: Dose Intensity of NIS973 and Spartalizumab NIS793 - cycle 3	—	3796.2 mg per cycle Standard Deviation 844.03	3550.0 mg per cycle Standard Deviation 982.59	—
Randomized Part: Dose Intensity of NIS973 and Spartalizumab Spartalizumab - cycle 1	—	400.0 mg per cycle Standard Deviation 0.00	—	—
Randomized Part: Dose Intensity of NIS973 and Spartalizumab Spartalizumab - cycle 3	—	400.0 mg per cycle Standard Deviation 0.00	—	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days

Population: Patients in the Safety set 2 who received gemcitabine or nab-paclitaxel at each reported treatment cycle

Dose intensity of gemcitabine and nab-paclitaxel was calculated as cumulative actual dose in milligrams/m\^2 divided by duration of exposure in days and multiplied by 28 days.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=45 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=46 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=49 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Gemcitabine - cycle 1	2392.1 mg per m^2 per cycle Standard Deviation 651.00	2442.3 mg per m^2 per cycle Standard Deviation 675.34	2644.8 mg per m^2 per cycle Standard Deviation 543.43	—
Randomized Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Gemcitabine - cycle 3	2445.3 mg per m^2 per cycle Standard Deviation 561.36	2293.9 mg per m^2 per cycle Standard Deviation 710.08	2426.5 mg per m^2 per cycle Standard Deviation 696.10	—
Randomized Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Nab-paclitaxel - cycle 1	298.8 mg per m^2 per cycle Standard Deviation 80.96	305.7 mg per m^2 per cycle Standard Deviation 84.91	330.7 mg per m^2 per cycle Standard Deviation 67.95	—
Randomized Part: Dose Intensity of Gemcitabine and Nab-paclitaxel Nab-paclitaxel - cycle 3	299.1 mg per m^2 per cycle Standard Deviation 70.08	286.2 mg per m^2 per cycle Standard Deviation 86.45	296.2 mg per m^2 per cycle Standard Deviation 88.06	—

SECONDARY outcome

Timeframe: Up to approximately 1.7 years

Population: Full Analysis Set (FAS)

ORR is the percentage of patients with a confirmed best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=52 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=50 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=51 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Overall Response Rate (ORR) Per RECIST v1.1	15.4 percentage of participants Interval 6.9 to 28.1	22.0 percentage of participants Interval 11.5 to 36.0	31.4 percentage of participants Interval 19.1 to 45.9	—

SECONDARY outcome

Timeframe: Up to approximately 1.7 years

Population: Participants in the Full Analysis Set (FAS) with CR or PR

DOR per RECIST v1.1 is defined as the time from the first documented response of CR or PR to the date of the first documented progression or death. DOR only applies to patients with a best overall response of CR or PR by investigator assessment per RECIST v1.1. Participants continuing without progression or death were censored at the date of their last adequate tumor assessment. DOR was analyzed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=8 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=11 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=16 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Duration of Response (DOR) Per RECIST v1.1	11.70 months Interval 3.61 to 16.2	7.75 months Interval 5.09 to Not estimable due to insufficient number of participants with events.	4.86 months Interval 3.71 to 7.39	—

SECONDARY outcome

Timeframe: Up to approximately 1.7 years

Population: Full Analysis Set (FAS)

TTP per RECIST v1.1 is defined as the time from the date of randomization to the date of event defined as the first documented progression per RECIST v1.1 or death due to underlying cancer. If a participant had no progression or death, the participant was censored at the date of last adequate tumor assessment. DOR was analyzed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=52 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=50 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=51 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Time to Progression (TTP) Per RECIST v1.1	5.36 months Interval 3.68 to 8.61	3.94 months Interval 3.55 to 7.03	5.59 months Interval 4.57 to 7.36	—

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Full Analysis Set (FAS)

Overall survival is defined as the time from the date of randomization to the date of death due to any cause. OS was analyzed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=52 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=50 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=51 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Overall Survival (OS)	10.1 months Interval 6.5 to 13.4	10.7 months Interval 7.2 to 12.7	8.5 months Interval 7.7 to 9.9	—

SECONDARY outcome

Timeframe: Baseline (Screening), on-treatment (anytime between Cycle 3 Day 2 and Day 4). The duration of each cycle was 28 days.

Population: Participants in the Full Analysis Set (FAS) who had a valid assessment of PD-L1 tumor expression at both baseline and on-treatment.

The tumor expression of programmed cell death-ligand 1 (PD-L1) was measured by immunohistochemical methods. Results are expressed as absolute change from baseline in PD-L1 expression.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=5 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=4 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=12 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Change From Baseline in PD-L1 Expression	4.000 percentage of PD-L1 positive tumor cells Standard Deviation 8.9443	7.625 percentage of PD-L1 positive tumor cells Standard Deviation 10.4193	7.917 percentage of PD-L1 positive tumor cells Standard Deviation 17.0572	—

SECONDARY outcome

Timeframe: Baseline (Screening), on-treatment (anytime between Cycle 3 Day 2 and Day 4). The duration of each cycle was 28 days.

Population: Participants in the Full Analysis Set (FAS) who had a valid assessment of CD8 tumor expression at both baseline and on-treatment.

The tumor expression of CD8 was measured by immunohistochemical methods. Results are expressed as absolute change from baseline in CD8 expression.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=6 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=3 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=14 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Change From Baseline in CD8 Expression	2.1 percentage of CD8 marker area expression Standard Deviation 1.82	10.1 percentage of CD8 marker area expression Standard Deviation 11.01	1.4 percentage of CD8 marker area expression Standard Deviation 2.64	—

SECONDARY outcome

Timeframe: Baseline (before first dose) and post-baseline (assessed throughout the treatment up to approximately 1.7 years)

Population: Participants in the safety set 2 who received NIS793 and had a non-missing baseline ADA sample and at least one non-missing post-baseline ADA sample.

The immunogenicity (IG) against NIS793 was assessed in serum using a validated enhanced electrochemiluminescence immunoassay (ECLIA). Patient anti-drug antibodies (ADA) status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline sample, all of which are ADA-negative samples * ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative post-baseline * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=41 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=44 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Number of Participants With Anti-NIS793 Antibodies ADA-negative at baseline	—	41 Participants	44 Participants	—
Randomized Part: Number of Participants With Anti-NIS793 Antibodies ADA-positive at baseline	—	0 Participants	0 Participants	—
Randomized Part: Number of Participants With Anti-NIS793 Antibodies ADA-negative post-baseline	—	41 Participants	44 Participants	—
Randomized Part: Number of Participants With Anti-NIS793 Antibodies ADA- inconclusive post-baseline	—	0 Participants	0 Participants	—
Randomized Part: Number of Participants With Anti-NIS793 Antibodies Treatment-induced ADA-positive	—	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days

Population: Participants in the safety set 2 who received spartalizumab and had a non-missing baseline ADA sample and at least one non-missing post-baseline ADA sample.

The immunogenicity (IG) against spartalizumab was assessed in serum using a validated a validated homogenous enzyme-linked immunosorbent assay (ELISA). Patient anti-drug antibodies (ADA) status was defined as follows: * ADA-negative at baseline: ADA-negative sample at baseline * ADA-inconclusive at baseline: patient who does not qualify as ADA-positive or ADA-negative at baseline * ADA-positive at baseline: ADA-positive sample at baseline * ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline sample, all of which are ADA-negative samples * ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative post-baseline * Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=41 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Number of Participants With Anti-spartalizumab Antibodies ADA-negative at baseline	—	40 Participants	—	—
Randomized Part: Number of Participants With Anti-spartalizumab Antibodies ADA- inconclusive at baseline	—	1 Participants	—	—
Randomized Part: Number of Participants With Anti-spartalizumab Antibodies ADA-positive at baseline	—	0 Participants	—	—
Randomized Part: Number of Participants With Anti-spartalizumab Antibodies ADA-negative post-baseline	—	35 Participants	—	—
Randomized Part: Number of Participants With Anti-spartalizumab Antibodies ADA- inconclusive post-baseline	—	2 Participants	—	—
Randomized Part: Number of Participants With Anti-spartalizumab Antibodies Treatment-induced ADA-positive	—	4 Participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 336 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days

Population: Participants in the pharmacokinetic analysis set (PAS) who received NIS793 and had an available value for the outcome measure. PAS consisted of all patients who received one dose (complete infusion) of the planned treatments and provided at least one valid primary PK parameter.

Pharmacokinetic (PK) parameters were calculated based on NIS793 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=42 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=39 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Maximum Observed Serum Concentration (Cmax) of NIS793 Cycle 1	—	603000 ng/mL Standard Deviation 181000	622000 ng/mL Standard Deviation 192000	—
Randomized Part: Maximum Observed Serum Concentration (Cmax) of NIS793 Cycle 3	—	821000 ng/mL Standard Deviation 235000	784000 ng/mL Standard Deviation 286000	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 336 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days

PK parameters were calculated based on NIS793 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=42 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=39 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of NIS793 Cycle 1	—	84700000 h*ng/mL Standard Deviation 29300000	96000000 h*ng/mL Standard Deviation 26100000	—
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of NIS793 Cycle 3	—	153000000 h*ng/mL Standard Deviation 52300000	151000000 h*ng/mL Standard Deviation 55000000	—

SECONDARY outcome

Timeframe: Cycle 1: pre-dose on Day 1. Cycle 3: pre-dose on Day 1 and Day 15 (combined). One cycle=28 days

Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=26 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=34 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Trough Serum Concentration (Ctrough) of NIS793 Cycle 1	—	137000 ng/mL Standard Deviation 51700	156000 ng/mL Standard Deviation 50100	—
Randomized Part: Trough Serum Concentration (Ctrough) of NIS793 Cycle 3	—	289000 ng/mL Standard Deviation 121000	291000 ng/mL Standard Deviation 126000	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 648 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days

Population: Participants in the pharmacokinetic analysis set (PAS) who received spartalizumab and had an available value for the outcome measure. PAS consisted of all patients who received one dose (complete infusion) of the planned treatments and provided at least one valid primary PK parameter.

PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=42 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Maximum Observed Serum Concentration (Cmax) of Spartalizumab Cycle 1	—	109 µg/mL Standard Deviation 22.4	—	—
Randomized Part: Maximum Observed Serum Concentration (Cmax) of Spartalizumab Cycle 3	—	120 µg/mL Standard Deviation 38.0	—	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 648 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days

PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=42 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab Cycle 1	—	10800 h*µg/mL Standard Deviation 4900	—	—
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab Cycle 3	—	3240 h*µg/mL Standard Deviation 1900	—	—

SECONDARY outcome

Timeframe: Cycle 2, 3 and 4: pre-dose on Day 1. One cycle=28 days

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=32 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Trough Serum Concentration (Ctrough) of Spartalizumab Cycle 2	—	22.3 µg/mL Standard Deviation 8.67	—	—
Randomized Part: Trough Serum Concentration (Ctrough) of Spartalizumab Cycle 3	—	31.9 µg/mL Standard Deviation 11.7	—	—
Randomized Part: Trough Serum Concentration (Ctrough) of Spartalizumab Cycle 4	—	30.5 µg/mL Standard Deviation 14.3	—	—

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 4: pre-dose, end of infusion, and 2, 3, 5 and 24 hours after the start of infusion on Day 1. The duration of the infusion was according to the product labelling and local guidance. One cycle=28 days

Population: Participants in the pharmacokinetic analysis set (PAS) who received gemcitabine and had an available value for the outcome measure. PAS consisted of all patients who received one dose (complete infusion) of the planned treatments and provided at least one valid primary PK parameter.

PK parameters were calculated based on gemcitabine plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=44 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=42 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=40 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Maximum Observed Plasma Concentration (Cmax) of Gemcitabine Cycle 1	10600 ng/mL Standard Deviation 6170	9830 ng/mL Standard Deviation 8580	12000 ng/mL Standard Deviation 6850	—
Randomized Part: Maximum Observed Plasma Concentration (Cmax) of Gemcitabine Cycle 4	7000 ng/mL Standard Deviation 4210	7950 ng/mL Standard Deviation 5650	8830 ng/mL Standard Deviation 6150	—

SECONDARY outcome

PK parameters were calculated based on gemcitabine plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=44 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=42 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=40 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Gemcitabine Cycle 1	8040 h*ng/mL Standard Deviation 4490	7270 h*ng/mL Standard Deviation 6950	9900 h*ng/mL Standard Deviation 6140	—
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Gemcitabine Cycle 4	4920 h*ng/mL Standard Deviation 2830	5270 h*ng/mL Standard Deviation 4730	5980 h*ng/mL Standard Deviation 4410	—

SECONDARY outcome

Timeframe: Cycle 4: pre-dose on Day 1. One cycle=28 days

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=23 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=24 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=30 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Trough Serum Concentration (Ctrough) of Gemcitabine	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	—

SECONDARY outcome

Population: Participants in the pharmacokinetic analysis set (PAS) who received nab-paclitaxel and had an available value for the outcome measure. PAS consisted of all patients who received one dose (complete infusion) of the planned treatments and provided at least one valid primary PK parameter.

PK parameters were calculated based on nab-paclitaxel plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=43 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=37 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=38 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel Cycle 1	3490 ng/mL Standard Deviation 1760	9990 ng/mL Standard Deviation 37100	4120 ng/mL Standard Deviation 3370	—
Randomized Part: Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel Cycle 4	2900 ng/mL Standard Deviation 1370	4570 ng/mL Standard Deviation 4910	4050 ng/mL Standard Deviation 2410	—

SECONDARY outcome

PK parameters were calculated based on nab-paclitaxel plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=43 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=37 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=38 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel Cycle 1	4820 h*ng/mL Standard Deviation 2500	15700 h*ng/mL Standard Deviation 52400	5080 h*ng/mL Standard Deviation 2820	—
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel Cycle 4	4250 h*ng/mL Standard Deviation 2550	5960 h*ng/mL Standard Deviation 3650	5020 h*ng/mL Standard Deviation 3050	—

SECONDARY outcome

Timeframe: Cycle 4: pre-dose on Day 1. One cycle=28 days

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=23 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=19 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=30 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel Standard of care chemotherapy in the randomized part
Randomized Part: Trough Serum Concentration (Ctrough) of Nab-paclitaxel	3.25 ng/mL Standard Deviation 5.08	455 ng/mL Standard Deviation 1320	2.13 ng/mL Standard Deviation 10.4	—

POST_HOC outcome

Timeframe: On-treatment and post-treatment safety FU deaths: up to approximately 1 year (run-in part) and 1.9 years (randomized part). Survival FU deaths: up to approximately 1.8 years (run-in part) and 2 years (randomized part)

Population: Safety set 1 (safety run-in) and Full Analysis Set (randomized part)

On-treatment and post-treatment safety follow-up (FU) deaths were collected from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer. Survival FU deaths were collected from 91 days after last dose of NIS793, 151 days after last dose of spartalizumab and 31 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, until end of study. All deaths refer to the sum of pre-treatment deaths, on-treatment and post-treatment safety FU deaths, and survival FU deaths.

Outcome measures

Outcome measures
Measure	Arm 3: Gemcitabine/Nab-paclitaxel n=51 Participants Standard of care chemotherapy in the randomized part	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel n=11 Participants NIS793 2100 mg every 2 weeks i.v. with spartalizumab 400 mg every 4 weeks i.v and standard of care chemotherapy in the randomized part	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel n=50 Participants NIS793 2100 mg every 2 weeks i.v. with standard of care chemotherapy in the randomized part	Arm 3: Gemcitabine/Nab-paclitaxel n=52 Participants Standard of care chemotherapy in the randomized part
All-Collected Deaths On-treatment and post-treatment safety FU deaths	19 Participants	5 Participants	18 Participants	4 Participants
All-Collected Deaths Survival FU deaths	22 Participants	5 Participants	15 Participants	35 Participants
All-Collected Deaths All deaths	41 Participants	10 Participants	33 Participants	39 Participants

Adverse Events

Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment

Serious events: 8 serious events

Other events: 11 other events

Deaths: 5 deaths

Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment

Serious events: 34 serious events

Other events: 45 other events

Deaths: 18 deaths

Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_On- and Post-treatment

Serious events: 28 serious events

Other events: 48 other events

Deaths: 19 deaths

Arm 3: Gemcitabine/Nab-paclitaxel_On- and Post-treatment

Serious events: 26 serious events

Other events: 40 other events

Deaths: 4 deaths

All Participants_On- and Post-treatment

Serious events: 96 serious events

Other events: 144 other events

Deaths: 46 deaths

Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_Survival Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

Arm 3: Gemcitabine/Nab-paclitaxel_Survival Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 35 deaths

Serious adverse events

Serious adverse events
Measure	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=11 participants at risk Safety data up to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=46 participants at risk Safety data up to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=49 participants at risk Safety data up to 90 days after last dose of NIS793 and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Arm 3: Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=45 participants at risk Safety data up to 30 days after last dose of gemcitabine and nab-paclitaxel	All Participants_On- and Post-treatment n=151 participants at risk Safety data up to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 90 after last dose of NIS793, Day 151 days after last dose of spartalizumab and Day 31 after last dose of gemcitabine and nab-paclitaxel, whichever was longer). No AEs were collected during this period.	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 90 after last dose of NIS793, Day 151 days after last dose of spartalizumab and Day 31 after last dose of gemcitabine and nab-paclitaxel, whichever was longer). No AEs were collected during this period.	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 90 after last dose of NIS793 and Day 31 after last dose of gemcitabine and nab-paclitaxel, whichever was longer). No AEs were collected during this period.	Arm 3: Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 31 after last dose of gemcitabine and nab-paclitaxel). No AEs were collected during this period.
Blood and lymphatic system disorders Anaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	12.2% 6/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Haemolysis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Leukopenia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Neutropenia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Cardiac disorders Pericardial effusion	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Cardiac disorders Supraventricular tachycardia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Endocrine disorders Glucocorticoid deficiency	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Endocrine disorders Hypopituitarism	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.0% 6/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Colitis	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Constipation	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.9% 5/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Diarrhoea haemorrhagic	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Duodenal obstruction	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Duodenal perforation	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Enterocolitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gastritis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gastritis haemorrhagic	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Haematemesis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Ileus	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Melaena	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Nausea	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Pancreatitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Subileus	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Vomiting	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Asthenia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Chest pain	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Chills	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Fatigue	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Gait inability	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders General physical health deterioration	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Non-cardiac chest pain	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Pain	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Pyrexia	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.9% 5/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.1% 5/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	9.9% 15/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Biliary obstruction	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Cholangitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Cholecystitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Gallbladder rupture	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Hepatic failure	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Hepatitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Abdominal infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Acarodermatitis	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Anal abscess	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Bacteraemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Biliary sepsis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Biliary tract infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations COVID-19	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations COVID-19 pneumonia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Campylobacter infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Device related infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Febrile infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Large intestine infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Lower respiratory tract infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Pneumonia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Pneumonia bacterial	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Pneumonia pseudomonal	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Postoperative wound infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Relapsing fever	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Sepsis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Septic shock	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Urinary tract infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Craniofacial fracture	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Fall	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Head injury	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Alanine aminotransferase increased	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Aspartate aminotransferase increased	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Blood bilirubin increased	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Gamma-glutamyltransferase increased	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations General physical condition abnormal	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Myocardial necrosis marker increased	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Musculoskeletal and connective tissue disorders Degenerative bone disease	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour obstruction	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Hepatic encephalopathy	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Syncope	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Renal and urinary disorders Bladder tamponade	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Renal and urinary disorders Haematuria	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Renal and urinary disorders Proteinuria	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Renal and urinary disorders Renal failure	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Reproductive system and breast disorders Orchitis noninfective	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Deep vein thrombosis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Hypotension	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Venous thrombosis	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).

Other adverse events

Other adverse events
Measure	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=11 participants at risk Safety data up to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=46 participants at risk Safety data up to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=49 participants at risk Safety data up to 90 days after last dose of NIS793 and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Arm 3: Gemcitabine/Nab-paclitaxel_On- and Post-treatment n=45 participants at risk Safety data up to 30 days after last dose of gemcitabine and nab-paclitaxel	All Participants_On- and Post-treatment n=151 participants at risk Safety data up to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 90 after last dose of NIS793, Day 151 days after last dose of spartalizumab and Day 31 after last dose of gemcitabine and nab-paclitaxel, whichever was longer). No AEs were collected during this period.	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 90 after last dose of NIS793, Day 151 days after last dose of spartalizumab and Day 31 after last dose of gemcitabine and nab-paclitaxel, whichever was longer). No AEs were collected during this period.	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 90 after last dose of NIS793 and Day 31 after last dose of gemcitabine and nab-paclitaxel, whichever was longer). No AEs were collected during this period.	Arm 3: Gemcitabine/Nab-paclitaxel_Survival Period Deaths collected in the survival follow-up period (starting from Day 31 after last dose of gemcitabine and nab-paclitaxel). No AEs were collected during this period.
Blood and lymphatic system disorders Anaemia	45.5% 5/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	63.0% 29/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	67.3% 33/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	44.4% 20/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	57.6% 87/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Leukocytosis	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.0% 6/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Leukopenia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Neutropenia	45.5% 5/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	23.9% 11/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	18.4% 9/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	20.0% 9/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	22.5% 34/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Neutrophilia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Blood and lymphatic system disorders Thrombocytopenia	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.2% 7/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.2% 4/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.3% 17/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	18.4% 9/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.9% 18/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Abdominal pain upper	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	16.3% 8/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.1% 5/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.9% 18/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Aphthous ulcer	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Constipation	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	34.8% 16/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	32.7% 16/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	26.7% 12/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	29.8% 45/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Diarrhoea	45.5% 5/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	56.5% 26/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	38.8% 19/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	40.0% 18/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	45.0% 68/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Dry mouth	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.2% 4/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	5.3% 8/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Dyspepsia	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.2% 5/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gingival bleeding	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	12.2% 6/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.0% 9/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gingival hypertrophy	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Gingival swelling	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Haemorrhoids	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Ileal perforation	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Ileus	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Nausea	63.6% 7/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	43.5% 20/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	55.1% 27/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	44.4% 20/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	49.0% 74/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Rectal haemorrhage	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Stomatitis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.2% 4/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Tongue coated	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Tongue disorder	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Gastrointestinal disorders Vomiting	27.3% 3/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	21.7% 10/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	36.7% 18/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	26.7% 12/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	28.5% 43/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Asthenia	45.5% 5/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	26.1% 12/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	32.7% 16/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	24.4% 11/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	29.1% 44/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Chills	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.1% 5/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	7.3% 11/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Fatigue	63.6% 7/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	50.0% 23/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	36.7% 18/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	31.1% 14/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	41.1% 62/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Mucosal inflammation	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.9% 5/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.2% 4/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	7.3% 11/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Oedema	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.0% 6/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Oedema peripheral	36.4% 4/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	23.9% 11/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	30.6% 15/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	17.8% 8/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	25.2% 38/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Pain	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
General disorders Pyrexia	63.6% 7/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	41.3% 19/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	22.4% 11/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	31.1% 14/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	33.8% 51/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Hepatobiliary disease	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Hepatobiliary disorders Immune-mediated hepatitis	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations COVID-19	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	28.3% 13/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	12.2% 6/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.1% 5/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	16.6% 25/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Infection	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Pneumonia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Infections and infestations Urinary tract infection	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.2% 7/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	12.2% 6/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	9.3% 14/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Fall	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Infusion related reaction	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Injury, poisoning and procedural complications Wound dehiscence	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	1.3% 2/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Alanine aminotransferase increased	36.4% 4/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	30.4% 14/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	20.4% 10/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	22.2% 10/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	25.2% 38/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Amylase increased	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.9% 5/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Aspartate aminotransferase increased	36.4% 4/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	28.3% 13/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	18.4% 9/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.6% 7/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	21.9% 33/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Blood alkaline phosphatase increased	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	7.3% 11/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Blood bilirubin increased	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.2% 5/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Blood creatinine increased	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Blood lactate dehydrogenase increased	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.0% 6/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations C-reactive protein increased	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.0% 6/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Gamma-glutamyltransferase increased	36.4% 4/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	5.3% 8/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Lipase increased	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.9% 5/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	7.9% 12/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Neutrophil count decreased	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.2% 7/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	16.3% 8/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	20.0% 9/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	17.2% 26/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Platelet count decreased	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	17.4% 8/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	20.4% 10/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	20.0% 9/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	18.5% 28/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Tri-iodothyronine decreased	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations Weight decreased	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	12.2% 6/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.1% 5/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	9.9% 15/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Investigations White blood cell count decreased	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.0% 9/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Decreased appetite	36.4% 4/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	21.7% 10/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	34.7% 17/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	33.3% 15/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	30.5% 46/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	5.3% 8/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypocalcaemia	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypochloraemia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypokalaemia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	17.4% 8/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	12.2% 6/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	20.0% 9/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.9% 24/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hyponatraemia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.0% 6/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Metabolism and nutrition disorders Hypophosphataemia	27.3% 3/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	19.6% 9/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	14.3% 7/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	13.9% 21/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.2% 5/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	17.8% 8/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.9% 18/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	13.0% 6/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.2% 5/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	9.3% 14/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	5.3% 8/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.2% 5/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.6% 7/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Dizziness	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	5.3% 8/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Dysgeusia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	13.0% 6/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.2% 5/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.6% 16/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Headache	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.0% 6/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Hypoaesthesia	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.0% 9/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Neuropathy peripheral	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.9% 5/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	22.4% 11/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.1% 5/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	13.9% 21/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Neurotoxicity	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	3.3% 5/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Paraesthesia	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	13.3% 6/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	9.9% 15/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Nervous system disorders Polyneuropathy	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.9% 5/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	10.2% 5/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	7.9% 12/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Psychiatric disorders Anxiety	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.2% 4/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.6% 7/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Psychiatric disorders Insomnia	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.6% 7/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	9.9% 15/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Renal and urinary disorders Haematuria	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Reproductive system and breast disorders Prostatomegaly	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	22.4% 11/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	26.7% 12/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	17.9% 27/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	16.3% 8/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.6% 7/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.3% 17/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Epistaxis	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	23.9% 11/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	28.6% 14/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	18.5% 28/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.6% 4/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.0% 9/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Acne	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Alopecia	27.3% 3/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	23.9% 11/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	30.6% 15/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	15.6% 7/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	23.8% 36/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.6% 7/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Erythema	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.1% 3/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.0% 9/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Night sweats	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 3/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Onycholysis	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Pruritus	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	30.4% 14/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	16.3% 8/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.2% 1/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	16.6% 25/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Rash	54.5% 6/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	28.3% 13/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	36.7% 18/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	11.1% 5/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	27.8% 42/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Rash macular	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Rash maculo-papular	18.2% 2/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	21.7% 10/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	2.0% 1/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.6% 13/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Skin and subcutaneous tissue disorders Skin toxicity	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Deep vein thrombosis	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.3% 2/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.1% 2/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.7% 3/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.6% 7/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Hypertension	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.5% 3/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.2% 4/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	4.4% 2/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	6.6% 10/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Hypotension	0.00% 0/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.7% 4/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	12.2% 6/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	8.9% 4/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	9.3% 14/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Jugular vein thrombosis	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).
Vascular disorders Vein rupture	9.1% 1/11 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/46 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/49 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.00% 0/45 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	0.66% 1/151 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).	— 0/0 • On- and post-treatment safety FU: from first dose of study treatment to 90 days after last dose of NIS793, 150 days after last dose of spartalizumab and 30 days after last dose of gemcitabine and nab-paclitaxel, whichever was longer, up to approx. 1 year (run-in part) and 1.9 years (randomized part). Deaths in survival period: after completing safety FU until end of study, up to approx. 1.8 years (run-in part) and 2 years (randomized part). Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period. Deaths were assessed in the Safety set 1 (run-in part) and Full Analysis Set (randomized part). AEs were assessed in the Safety set 1 (run-in part) and Safety set 2 (randomized part).

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER