Trial Outcomes & Findings for Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer (NCT NCT05577702)

NCT ID: NCT05577702

Last Updated: 2026-02-09

Results Overview

Tumor tissue and lymph node tissue obtained from surgical resection were sent to a central laboratory according to study pathology manuals for pathological response analysis. MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR). Participants without surgery or pathological results were considered non-responders.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 121 participants
• Primary outcome timeframe: At the time of surgery, approximately Week 16
• Results posted on: 2026-02-09

Participant Flow

This study enrolled 121 participants at study sites in China.

In Substudy 1 participants with programmed death-ligand 1 (PD-L1) expression ≥ 50% were randomized to 1 of 3 treatment groups in a 1:1:1 ratio. In Substudy 2 participants with PD-L1 expression < 50% were randomized into 1 of 2 treatment groups in a 1:2 ratio.

Participant milestones

Measure	Arm 1A: Tislelizumab Monotherapy Participants with tumor programmed death protein ligand-1 (PD-L1) expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Overall Study STARTED	20	20	20	20	41
Overall Study Treated	20	20	20	19	40
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	20	20	20	20	41

Reasons for withdrawal

Measure	Arm 1A: Tislelizumab Monotherapy Participants with tumor programmed death protein ligand-1 (PD-L1) expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Overall Study Study Ended by Sponsor	19	17	19	16	38
Overall Study Death	1	2	1	3	2
Overall Study Withdrawal by Subject	0	1	0	1	1

Baseline Characteristics

Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Total n=121 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 6.68 • n=362 Participants	63.1 years STANDARD_DEVIATION 6.78 • n=3 Participants	62.7 years STANDARD_DEVIATION 8.03 • n=7 Participants	61.0 years STANDARD_DEVIATION 6.86 • n=17 Participants	61.9 years STANDARD_DEVIATION 9.76 • n=96 Participants	62.3 years STANDARD_DEVIATION 8.03 • n=2 Participants
Sex: Female, Male Female	2 Participants n=362 Participants	1 Participants n=3 Participants	3 Participants n=7 Participants	3 Participants n=17 Participants	10 Participants n=96 Participants	19 Participants n=2 Participants
Sex: Female, Male Male	18 Participants n=362 Participants	19 Participants n=3 Participants	17 Participants n=7 Participants	17 Participants n=17 Participants	31 Participants n=96 Participants	102 Participants n=2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=362 Participants	20 Participants n=3 Participants	20 Participants n=7 Participants	20 Participants n=17 Participants	41 Participants n=96 Participants	121 Participants n=2 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Race (NIH/OMB) Asian	20 Participants n=362 Participants	20 Participants n=3 Participants	20 Participants n=7 Participants	20 Participants n=17 Participants	41 Participants n=96 Participants	121 Participants n=2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Race (NIH/OMB) Black or African American	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Race (NIH/OMB) White	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Race (NIH/OMB) More than one race	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants	0 Participants n=96 Participants	0 Participants n=2 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Fully Active)	9 Participants n=362 Participants	7 Participants n=3 Participants	8 Participants n=7 Participants	9 Participants n=17 Participants	22 Participants n=96 Participants	55 Participants n=2 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Ambulatory with Restricted Activities)	11 Participants n=362 Participants	13 Participants n=3 Participants	12 Participants n=7 Participants	11 Participants n=17 Participants	19 Participants n=96 Participants	66 Participants n=2 Participants
Smoking Status Current	3 Participants n=362 Participants	1 Participants n=3 Participants	4 Participants n=7 Participants	2 Participants n=17 Participants	5 Participants n=96 Participants	15 Participants n=2 Participants
Smoking Status Former	15 Participants n=362 Participants	15 Participants n=3 Participants	12 Participants n=7 Participants	15 Participants n=17 Participants	22 Participants n=96 Participants	79 Participants n=2 Participants
Smoking Status Never	2 Participants n=362 Participants	4 Participants n=3 Participants	4 Participants n=7 Participants	3 Participants n=17 Participants	14 Participants n=96 Participants	27 Participants n=2 Participants

PRIMARY outcome

Timeframe: At the time of surgery, approximately Week 16

Population: The Intent-to-Treat (ITT) analysis set includes all enrolled participants.

Tumor tissue and lymph node tissue obtained from surgical resection were sent to a central laboratory according to study pathology manuals for pathological response analysis. MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR). Participants without surgery or pathological results were considered non-responders.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Major Pathological Response (MPR) Rate	45.0 percentage of participants Interval 23.1 to 68.5	50.0 percentage of participants Interval 27.2 to 72.8	40.0 percentage of participants Interval 19.1 to 63.9	55.0 percentage of participants Interval 31.5 to 76.9	34.1 percentage of participants Interval 20.1 to 50.6

SECONDARY outcome

Timeframe: At the time of surgery, approximately Week 16

Population: Intent to treat analysis set

Pathological complete response is defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR. Participants without surgery or pathological results were considered as non-responders.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Pathological Complete Response (pCR)	30.0 percentage of participants Interval 11.9 to 54.3	30.0 percentage of participants Interval 11.9 to 54.3	40.0 percentage of participants Interval 19.1 to 63.9	35.0 percentage of participants Interval 15.4 to 59.2	17.1 percentage of participants Interval 7.2 to 32.1

SECONDARY outcome

Timeframe: From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.

Population: Intent to treat analysis set

EFS is defined as the time from randomization until any of the following events, whichever occurred first: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. Median EFS was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Event-free Survival (EFS)	NA months Interval 10.3 to Could not be estimated due to insufficient number of events	NA months Interval 3.7 to Could not be estimated due to insufficient number of events	11.4 months Interval 11.4 to Could not be estimated due to insufficient number of events	11.6 months Interval 7.9 to Could not be estimated due to insufficient number of events	NA months Interval 10.9 to Could not be estimated due to insufficient number of events

SECONDARY outcome

Timeframe: 12 months and 24 months after randomization

Population: Intent to treat analysis set

Event-free survival rate is defined as the percentage of participants with none of the following events: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. EFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Event-free Survival Rate 24 months	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	0.0 percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time
Event-free Survival Rate 12 months	75.3 percentage of participants Interval 24.5 to 94.4	60.0 percentage of participants Interval 17.8 to 86.0	44.0 percentage of participants Interval 1.1 to 86.1	0.0 percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	50.5 percentage of participants Interval 15.0 to 78.2

SECONDARY outcome

Timeframe: From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.

Population: Intent to treat analysis set

OS is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Overall Survival (OS)	NA months Could not be estimated due to an insufficient number of events	NA months Could not be estimated due to an insufficient number of events	NA months Interval 11.4 to Could not be estimated due to an insufficient number of events	NA months Interval 11.6 to Could not be estimated due to an insufficient number of events	NA months Could not be estimated due to an insufficient number of events

SECONDARY outcome

Timeframe: 12 months and 24 months after randomization

Population: Intent to treat analysis set

Overall survival rate is defined as the percentage of participants who were still alive at the analysis time points. OS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Overall Survival Rate 12 months	91.7 percentage of participants Interval 53.9 to 98.8	89.7 percentage of participants Interval 64.8 to 97.3	90.0 percentage of participants Interval 47.3 to 98.5	58.6 percentage of participants Interval 8.4 to 89.2	94.9 percentage of participants Interval 81.2 to 98.7
Overall Survival Rate 24 months	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time

SECONDARY outcome

Timeframe: From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.

Population: Participants in the intent to treat analysis set with planned surgery who have undergone R0 resection.

DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative [R0] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurred first. Median DFS was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=16 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=14 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=12 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=17 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=31 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Disease-free Survival (DFS)	NA months Interval 8.4 to Could not be estimated due to an insufficient number of events	NA months Interval 8.0 to Could not be estimated due to an insufficient number of events	NA months Interval 8.8 to Could not be estimated due to an insufficient number of events	8.7 months Interval 4.0 to Could not be estimated due to an insufficient number of events	NA months Interval 9.0 to Could not be estimated due to an insufficient number of events

SECONDARY outcome

Timeframe: 12 months and 24 months after randomization

Population: Participants in the intent to treat analysis set with planned surgery who have undergone R0 resection.

Disease-free survival rate is defined as the percentage of participants with none of the following events: Local or distant recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. DFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=16 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=14 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=12 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=17 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=31 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Disease-free Survival Rate 12 months	75.0 percentage of participants Interval 12.8 to 96.1	60.6 percentage of participants Interval 7.5 to 90.8	50.0 percentage of participants Interval 0.6 to 91.0	0.0 percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time
Disease-free Survival Rate 24 months	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	0.0 percentage of participants Could not be estimated due to an insufficient number of events and follow-up time	NA percentage of participants Could not be estimated due to an insufficient number of events and follow-up time

SECONDARY outcome

Timeframe: From first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.

Population: The safety analysis set included all enrolled participants who received ≥ 1 dose of neoadjuvant treatment.

A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:

• Resulted in death
• Was life-threatening
• Required hospitalization or prolongation of existing hospitalization
• Resulted in disability/incapacity
• Was a congenital anomaly/birth defect
• Was considered a significant medical AE by the investigator or sponsor based on medical judgement (eg, may have jeopardized the participant or may require medical/surgical intervention to prevent one of the outcomes listed above).

Immune-mediated adverse events (imAEs) are autoimmune-mediated complications that may develop in response to immunotherapeutic agents. Immune-mediated AEs were collected from the date of first dose of study drug to 90 days after the last dose of study drug, regardless of whether the participant started a new anticancer therapy or prespecified adjuvant treatment. imAEs were identified by the investigator based on a standard process defined in the Protocol.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=19 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=40 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Immune-mediated AEs	0 Participants	6 Participants	3 Participants	2 Participants	17 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE	7 Participants	14 Participants	15 Participants	19 Participants	39 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Serious adverse events	0 Participants	3 Participants	2 Participants	2 Participants	13 Participants

SECONDARY outcome

Timeframe: At the time of surgery, approximately Week 16

Population: Intent to treat analysis set

Feasibility of surgery was assessed by the number of participants who underwent surgical resection (surgery) within 6 weeks of last dose of study drug, had delayed or canceled surgery, the approach of surgery, duration of surgery (see next outcome measure) ,and the number of participants who underwent an exploratory thoracotomy, a surgical procedure in which a cut is made between the ribs to see and reach the lungs or other organs in the chest or thorax. Exploratory thoracotomy was not counted as surgery.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=20 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=41 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Feasibility of Surgery Received minimally invasive surgery	12 Participants	9 Participants	6 Participants	13 Participants	22 Participants
Feasibility of Surgery Underwent Surgery	16 Participants	14 Participants	12 Participants	17 Participants	31 Participants
Feasibility of Surgery Received open surgery	4 Participants	5 Participants	6 Participants	4 Participants	9 Participants
Feasibility of Surgery Received Exploratory Thoracotomy	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Feasibility of Surgery Delayed Surgery	7 Participants	3 Participants	3 Participants	2 Participants	8 Participants
Feasibility of Surgery No Surgery or Exploratory Thoracotomy	3 Participants	6 Participants	8 Participants	1 Participants	9 Participants

SECONDARY outcome

Timeframe: Approximately Week 16

Population: Participants in the intent to treat analysis set who underwent surgery and who had complete records of both surgery start and stop times recorded.

The duration of surgery is defined as the time interval from the start of the surgical procedure to its completion.

Outcome measures

Measure	Arm 1A: Tislelizumab Monotherapy n=15 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=14 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=12 Participants Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=17 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=31 Participants Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Duration of Surgery	3.33 hours Interval 2.5 to 5.3	3.50 hours Interval 2.3 to 5.3	3.39 hours Interval 2.3 to 8.7	4.30 hours Interval 2.7 to 8.0	4.05 hours Interval 2.0 to 6.6

Adverse Events

Arm 1A: Tislelizumab Monotherapy

Serious events: 0 serious events

Other events: 7 other events

Deaths: 1 deaths

Arm 1B: Tislelizumab + Ociperlimab

Serious events: 3 serious events

Other events: 14 other events

Deaths: 2 deaths

Arm 1C: Alcestobart + Tislelizumab

Serious events: 2 serious events

Other events: 14 other events

Deaths: 1 deaths

Arm 2A: Tislelizumab and Chemotherapy

Serious events: 2 serious events

Other events: 19 other events

Deaths: 3 deaths

Arm 2C: Alcestobart + Tislelizumab + Chemotherapy

Serious events: 13 serious events

Other events: 38 other events

Deaths: 2 deaths

Serious adverse events

Measure	Arm 1A: Tislelizumab Monotherapy n=20 participants at risk Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 participants at risk Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 participants at risk Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=19 participants at risk Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=40 participants at risk Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Blood and lymphatic system disorders Anaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Blood and lymphatic system disorders Leukopenia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Cardiac disorders Immune-mediated myocarditis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Cardiac disorders Myocardial injury	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Cardiac disorders Palpitations	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Endocrine disorders Hyperthyroidism	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Stomatitis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Pain	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Pyrexia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Immune system disorders Food allergy	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations Pneumonia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations Pneumonia bacterial	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations Pulmonary tuberculosis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Neutrophil count decreased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Platelet count decreased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Neurotoxicity	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.

Other adverse events

Measure	Arm 1A: Tislelizumab Monotherapy n=20 participants at risk Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.	Arm 1B: Tislelizumab + Ociperlimab n=20 participants at risk Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 1C: Alcestobart + Tislelizumab n=20 participants at risk Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2A: Tislelizumab and Chemotherapy n=19 participants at risk Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.	Arm 2C: Alcestobart + Tislelizumab + Chemotherapy n=40 participants at risk Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Blood and lymphatic system disorders Leukopenia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	31.6% 6/19 • Number of events 11 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	35.0% 14/40 • Number of events 28 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Blood and lymphatic system disorders Anaemia	5.0% 1/20 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 3/20 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	20.0% 4/20 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	52.6% 10/19 • Number of events 20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	57.5% 23/40 • Number of events 57 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Cardiac disorders Bradycardia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Cardiac disorders Cardiac failure	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Cardiac disorders Sinus bradycardia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 3/20 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Endocrine disorders Hyperthyroidism	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 4/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Endocrine disorders Hypothyroidism	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Endocrine disorders Thyroid disorder	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Eye disorders Vitreous floaters	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.8% 3/19 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Constipation	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	17.5% 7/40 • Number of events 9 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.8% 3/19 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Nausea	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	36.8% 7/19 • Number of events 8 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	17.5% 7/40 • Number of events 10 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.5% 2/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Asthenia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Chest pain	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Fatigue	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.5% 2/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	12.5% 5/40 • Number of events 8 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Influenza like illness	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Malaise	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 4/40 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Pain	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.5% 2/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
General disorders and administration site conditions Pyrexia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.8% 3/19 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations COVID-19	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations Fascioliasis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations Pneumonia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations Upper respiratory tract infection	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Infections and infestations Urinary tract infection	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Injury, poisoning and procedural complications Wound complication	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Alanine aminotransferase increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	20.0% 4/20 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	26.3% 5/19 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	25.0% 10/40 • Number of events 13 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Aspartate aminotransferase increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 3/20 • Number of events 6 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	20.0% 4/20 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	36.8% 7/19 • Number of events 8 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	25.0% 10/40 • Number of events 19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Bile acids increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Bilirubin conjugated increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood alkaline phosphatase increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood bilirubin increased	15.0% 3/20 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.5% 2/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 4/40 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood bilirubin unconjugated increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood creatine phosphokinase MB increased	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood creatine phosphokinase increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 6 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood homocysteine increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood iron decreased	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood lactate dehydrogenase increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 3/20 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	12.5% 5/40 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Blood urea increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations C-reactive protein increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Fibrin D dimer increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Gamma-glutamyltransferase increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Glucose urine present	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Haemoglobin decreased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations International normalised ratio increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Lung diffusion test decreased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Lymphocyte count decreased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.8% 3/19 • Number of events 6 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	12.5% 5/40 • Number of events 16 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Myoglobin blood increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Neutrophil count decreased	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	84.2% 16/19 • Number of events 39 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	67.5% 27/40 • Number of events 68 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Neutrophil count increased	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	12.5% 5/40 • Number of events 6 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Neutrophil percentage decreased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Neutrophil percentage increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Platelet count decreased	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	31.6% 6/19 • Number of events 6 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	17.5% 7/40 • Number of events 12 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Prohormone brain natriuretic peptide increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Prothrombin time prolonged	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Red blood cell count decreased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Serum amyloid A protein increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Troponin T increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Urine bilirubin increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Urobilinogen urine increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations Weight decreased	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations White blood cell count decreased	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	63.2% 12/19 • Number of events 30 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	50.0% 20/40 • Number of events 47 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations White blood cell count increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.5% 2/19 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Investigations pH urine increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.8% 3/19 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	27.5% 11/40 • Number of events 14 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 3/20 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.8% 3/19 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 6/40 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.5% 2/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 4/40 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.5% 2/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	12.5% 5/40 • Number of events 8 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	21.1% 4/19 • Number of events 6 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Coma	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Dizziness	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Headache	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Hemiplegia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Hydrocephalus	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Hypoaesthesia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	21.1% 4/19 • Number of events 7 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Intracranial aneurysm	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Intracranial pressure increased	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Paraesthesia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Psychiatric disorders Insomnia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	7.5% 3/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Psychiatric disorders Sleep disorder	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Renal and urinary disorders Haematuria	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Renal and urinary disorders Pollakiuria	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Renal and urinary disorders Proteinuria	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 2/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Renal and urinary disorders Renal impairment	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 3/20 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	10.0% 4/40 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.8% 3/19 • Number of events 4 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	2.5% 1/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	21.1% 4/19 • Number of events 5 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	25.0% 10/40 • Number of events 10 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Skin and subcutaneous tissue disorders Palmoplantar pustulosis	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	15.0% 3/20 • Number of events 3 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.3% 1/19 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	22.5% 9/40 • Number of events 15 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Vascular disorders Hypertension	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 2/40 • Number of events 2 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Vascular disorders Hypotension	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	5.0% 1/20 • Number of events 1 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/20 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/19 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.	0.00% 0/40 • Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.

Additional Information

Study Director

BeiGene

Phone: 1 877-828-5568

Email: clinicaltrials@beigene.com

Results disclosure agreements

• Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
• Publication restrictions are in place

Restriction type: OTHER