Trial Outcomes & Findings for Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143 (NCT NCT04122625)

Last Updated: 2023-06-12

Results Overview

DLT: any of following treatment-emergent adverse events (TEAEs) as per NCI CTCAE Grade V5.0 Criteria (Grades 1=mild, 2=moderate, 3=severe and 4 or 5= life-threatening/fatal outcomes) which are possibly, probably or definitely related to combination treatment and occurring in Cycle 1 (1 Cycle=28 days): Any Grade 4 or 5 hematologic toxicity, clinical or laboratory non-hematologic toxicity; febrile neutropenia any grade, Grade 3 thrombocytopenia if associated with bleeding or requiring platelet transfusion; Grade 2; Grade 3 and any other Grade 3 non-hematologic, treatment-related clinical toxicity lasting ≥3 days; delay of \>2 weeks due to drug-related toxicity in initiating Cycle 2; unable to complete at least 70% of the scheduled treatment (\>six Debio 1143 skipped doses in Cycle 1) due to treatment-related toxicity; required dose reduction in Cycle 1 or on Cycle 2 Day 1 or requirement for treatment withdrawal due to treatment-related toxicity (even if not meeting other DLT criteria).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Part A: Cycle 1 (28 days)

Results posted on

2023-06-12

Participant Flow

Participants took part at 24 investigational sites in the United States, Spain, and France from 26 April 2019 to 6 April 2022.

A total of 46 participants were enrolled in this study, 11 participants with advanced solid malignancies who failed prior systemic standard treatments into Part A and 35 participants into Part B of the study. Part B of the study was started after recommended phase 2 dose (RP2D) was determined in Part A and did not include any participants from Part A.

Participant milestones

Participant milestones
Measure	Part A - Debio 1143 150 mg + Nivolumab Participants received Debio 1143, 150 milligrams (mg) capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, intravenous (IV) infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Participants with small-cell lung cancer (SCLC) received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Participants with squamous cell carcinoma of the head and neck (SCCHN) received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with gastrointestinal (GI) cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A (up to 2.92 Years) STARTED	3	8	0	0	0	0
Part A (up to 2.92 Years) COMPLETED	1	4	0	0	0	0
Part A (up to 2.92 Years) NOT COMPLETED	2	4	0	0	0	0
Part B (up to 2.33 Years) STARTED	0	0	8	8	8	11
Part B (up to 2.33 Years) COMPLETED	0	0	2	0	0	4
Part B (up to 2.33 Years) NOT COMPLETED	0	0	6	8	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - Debio 1143 150 mg + Nivolumab Participants received Debio 1143, 150 milligrams (mg) capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, intravenous (IV) infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Participants with small-cell lung cancer (SCLC) received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Participants with squamous cell carcinoma of the head and neck (SCCHN) received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with gastrointestinal (GI) cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A (up to 2.92 Years) Death	2	4	0	0	0	0
Part B (up to 2.33 Years) Patient lost to follow-up	0	0	1	1	2	0
Part B (up to 2.33 Years) Death	0	0	5	7	6	7

Baseline Characteristics

Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Total n=46 Participants Total of all reporting groups
Age, Continuous	71.0 years n=5 Participants	55.5 years n=7 Participants	65.5 years n=5 Participants	61.6 years n=4 Participants	63.9 years n=21 Participants	64.8 years n=10 Participants	63.0 years n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=10 Participants	21 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	0 Participants n=10 Participants	25 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=10 Participants	34 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	11 Participants n=115 Participants
Race/Ethnicity, Customized Race · White	3 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=10 Participants	34 Participants n=115 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Race · Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	11 Participants n=115 Participants

PRIMARY outcome

Timeframe: Part A: Cycle 1 (28 days)

Population: Recommended phase 2 dose (RP2D) population included participants who received at least 70% of Debio 1143 (i.e., a maximum of 6 missed Debio 1143 doses) and at least one nivolumab dose as planned in Cycle 1.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=6 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Part B: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.05 years)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

ORR was determined per response evaluation criteria in solid tumors (RECIST) v1.1 and/or gynecologic cancer intergroup (GCIG) criteria (for Cohort 4). ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of partial response (PR) or complete response (CR) recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 millimeters (mm). PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=8 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part B: Confirmed Objective Response Rate (ORR)	0.0 percentage of participants Interval 0.0 to 37.0	0.0 percentage of participants Interval 0.0 to 37.0	0.0 percentage of participants Interval 0.0 to 37.0	9.1 percentage of participants Interval 0.0 to 41.0	—	—

SECONDARY outcome

Timeframe: From the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first. An SAE is defined as any untoward medical occurrence that at any dose results in death; is life-threatening (i.e., puts the participant at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs) TEAEs	3 Participants	8 Participants	8 Participants	8 Participants	8 Participants	11 Participants
Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs) SAEs	0 Participants	8 Participants	0 Participants	6 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=4 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=7 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=3 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=4 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Change From Baseline in Weight	-5.57 kilograms (kg) Standard Deviation 5.705	-10.00 kilograms (kg) Standard Deviation 9.416	-4.33 kilograms (kg) Standard Deviation 3.888	-4.00 kilograms (kg) Standard Deviation 6.557	-0.80 kilograms (kg) Standard Deviation 5.415	-1.11 kilograms (kg) Standard Deviation 1.680

SECONDARY outcome

Timeframe: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Vital sign parameters assessed comprise of systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Markedly abnormal criteria for vital signs include SBP \[millimeters of mercury (mmHg)\]: ≤ 90 mmHg OR change from baseline ≤ -20 mmHg, ≥ 140 mmHg OR change from baseline ≥ 20 mmHg; DBP (mmHg): ≤ 60 mmHg OR change from baseline ≤ -20 mmHg, ≥ 90 mmHg OR change from baseline ≥ 20 mmHg; Heart rate \[beats per minute (bpm)\]: ≤ 50 bpm OR change from baseline ≤ -20 bpm, ≥ 100 bpm OR change from baseline ≥ 20 bpm.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Change from baseline in temperature reported as TEAEs included pyrexia. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

ECG parameters comprised of PR Interval \[millisecond (msec)\], QRS Interval (msec), QT Interval (msec), QTcB Interval (msec), QTcF Interval (msec), heart rate (HR) (bpm), RR interval (msec), derived HR (msec), calculated as 60000/RR interval \[for data checking only: should be within 5% of HR\]. Marked abnormal criteria for ECG parameters included absolute values QRS interval: \< 50 msec, \> 110 msec; absolute values for QT interval, QTcB interval: \>450 msec, \> 480 msec, \> 500 msec, QTcF: \> 480 msec, \> 500 msec; change from baseline values for QTcB interval, and QTcF: \>30 msec increase from baseline, \>60 msec increase from baseline. Data for highest on-treatment change from baseline as per the markedly abnormal criteria for ECG parameters are reported. On-treatment is the period of time between the first and last administration of any study drug. Participants with at least one markedly abnormal change from baseline value in the above categories are reported.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=2 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QT Interval: >450 msec	0 Participants	1 Participants	2 Participants	1 Participants	3 Participants	0 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcB Interval: >500 msec	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcB Interval: >30 msec increase from baseline	0 Participants	4 Participants	3 Participants	5 Participants	3 Participants	6 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcB Interval: >60 msec increase from baseline	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcF Interval: >480 msec	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcF Interval: >30 msec increase from baseline	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants	4 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcF Interval: >60 msec increase from baseline	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QRS duration: >110 msec	0 Participants	3 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QT Interval: >480 msec	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcB Interval: >450 msec	2 Participants	2 Participants	3 Participants	5 Participants	1 Participants	5 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcB Interval: >480 msec	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcB Interval: >30 msec or >60 msec increase from baseline	0 Participants	4 Participants	3 Participants	6 Participants	3 Participants	6 Participants
Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings QTcF Interval: >500 msec	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

The ECOG-PS was used to assess the effect of disease progression on participants' daily activities. ECOG-PS is graded as follows: Grade 0 - fully active, able to carry on all pre-disease performance without restriction; Grade 1 - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2 - ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3 - capable of only limited self-care, confined to bed or chair for more than 50% of waking hours; Grade 4 - completely disabled, cannot carry on any self-care, totally confined to bed or chair; Grade 5 - dead. Shift values from baseline grade to worst on-treatment grade and missing values were reported.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Shift From Grade 0 to Grade 0	1 Participants	3 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Shift From Grade 0 to Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Shift From Grade 1 to Grade 1	2 Participants	1 Participants	2 Participants	3 Participants	2 Participants	5 Participants
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Shift From Grade 1 to Grade 2	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Shift From Grade 0 to Grade 1	0 Participants	2 Participants	3 Participants	0 Participants	2 Participants	4 Participants
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Shift From Grade 0 to Grade 2	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Shift From Grade 1 to Grade 3	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications TEAEs Leading to Discontinuation of Nivolumab	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants	2 Participants
Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications TEAEs Leading to Dose Modification of Debio 1143	2 Participants	5 Participants	5 Participants	5 Participants	3 Participants	4 Participants
Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications TEAEs Leading to Dose Modification of Nivolumab	2 Participants	6 Participants	4 Participants	5 Participants	1 Participants	4 Participants
Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications TEAEs Leading to Discontinuation of Debio 1143	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Part A: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

ORR was determined per RECIST v1.1. ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A: Confirmed Objective Response Rate (ORR)	0.0 percentage of participants	12.5 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

uORR was calculated as the percentage of participants with unconfirmed objective response per RECIST v1.1. Unconfirmed objective response is an unconfirmed best overall response of PR or CR. Objective response was derived as any PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Unconfirmed Objective Response Rate (uORR)	0.0 percentage of participants	25.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	9.1 percentage of participants

SECONDARY outcome

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

DCR was calculated as the percentage of participants with disease control. Disease control was derived as any CR, PR, or stable disease reported during the study. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Disease Control Rate (DCR)	66.7 percentage of participants	50.0 percentage of participants	25.0 percentage of participants	75.0 percentage of participants	37.5 percentage of participants	45.5 percentage of participants

SECONDARY outcome

DOR is defined as the time, in months, between date of the initial response (PR or CR) or date of first reduction of 50% in carbohydrate antigen 125 (CA-125), and date of the first documented disease progression or death due to any cause, whichever occurs first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to \<10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter. Data is reported as Kaplan-Meier product-limit estimates.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=2 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=1 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Median Duration of Response (DOR)	—	NA months The median and the 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.	—	—	—	NA months The median and the 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From the start of study treatment until disease progression/recurrence or death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

PFS duration is defined as the time, in months, elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Progression Free Survival (PFS)	2.3 months Interval 1.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	2.3 months Interval 0.3 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.8 months Interval 1.0 to 3.2	1.9 months Interval 0.9 to 3.5	1.2 months Interval 0.8 to 4.2	1.8 months Interval 1.3 to 5.2

SECONDARY outcome

Timeframe: Months 6 and 12

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants analyzed at the given time points. No participants were analyzed at Month 12 in Part B.

PFS is defined as duration elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first. Data for PFS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: PFS Rate at Months 6 and 12 Month 6	0.0 proportion of participants Interval 0.0 to 0.0	0.2 proportion of participants Interval 0.0 to 0.5	0.1 proportion of participants Interval 0.0 to 0.4	0.0 proportion of participants Interval 0.0 to 0.0	0.1 proportion of participants Interval 0.0 to 0.4	0.2 proportion of participants Interval 0.0 to 0.4
Parts A and B: PFS Rate at Months 6 and 12 Month 12	0.0 proportion of participants Interval 0.0 to 0.0	0.2 proportion of participants Interval 0.0 to 0.5	—	—	—	—

SECONDARY outcome

Timeframe: From the start of study treatment until death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

OS is defined as the time elapsed, in months, between treatment initiation and death from any cause.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Overall Survival (OS)	13.8 months Interval 12.5 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA months Interval 1.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	17.5 months Interval 3.8 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	4.7 months Interval 0.9 to 13.4	5.2 months Interval 1.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	11.7 months Interval 3.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Months 12 and 18

OS is defined as the time elapsed, in months, between treatment initiation and death from any cause. Data for OS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: OS Rate at Months 12 and 18 Month 12	1.0 proportion of participants Interval 1.0 to 1.0	0.5 proportion of participants Interval 0.2 to 0.8	0.9 proportion of participants Interval 0.4 to 1.0	0.3 proportion of participants Interval 0.0 to 0.6	0.4 proportion of participants Interval 0.1 to 0.7	0.4 proportion of participants Interval 0.1 to 0.7
Parts A and B: OS Rate at Months 12 and 18 Month 18	NA proportion of participants The median and 95% CI were not estimable due to insufficient number of participants with events.	NA proportion of participants The median and 95% CI were not estimable due to insufficient number of participants with events.	0.5 proportion of participants Interval 0.2 to 0.8	0.1 proportion of participants Interval 0.0 to 0.4	0.4 proportion of participants Interval 0.1 to 0.7	0.3 proportion of participants Interval 0.0 to 0.6

SECONDARY outcome

Timeframe: Cycle 1: predose, 0.5, 1.5, 4 hours post-dose on Days 1 and 15, predose, 1.5, 4 hours post-dose on Days 8 and 22; Cycle 3: predose, 0.5, 1.5, 4 hours post-dose on Day 1 and predose, 1.5, 4 hours post-dose on Day 15 (each cycle=28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 1	6200.28 hoursnanograms per milliliter (hng/mL) Standard Deviation 330.246	4907.15 hoursnanograms per milliliter (hng/mL) Standard Deviation 2496.914	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 8	4321.40 hoursnanograms per milliliter (hng/mL) Standard Deviation 1127.611	5861.53 hoursnanograms per milliliter (hng/mL) Standard Deviation 3764.659	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 15	5081.21 hoursnanograms per milliliter (hng/mL) Standard Deviation 868.905	5114.03 hoursnanograms per milliliter (hng/mL) Standard Deviation 3168.408	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 22	4517.00 hoursnanograms per milliliter (hng/mL) Standard Deviation 3539.938	4086.09 hoursnanograms per milliliter (hng/mL) Standard Deviation 2516.921	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 1	4053.97 hoursnanograms per milliliter (hng/mL) Standard Deviation 3005.430	6844.02 hoursnanograms per milliliter (hng/mL) Standard Deviation 4940.667	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 15	4725.37 hoursnanograms per milliliter (hng/mL) Standard Deviation 2033.252	5934.72 hoursnanograms per milliliter (hng/mL) Standard Deviation 2251.520	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 1	2624.48 hoursnanograms per milliliter (hng/mL) Standard Deviation 953.275	1662.25 hoursnanograms per milliliter (hng/mL) Standard Deviation 957.856	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 8	3884.59 hoursnanograms per milliliter (hng/mL) Standard Deviation 565.589	5133.24 hoursnanograms per milliliter (hng/mL) Standard Deviation 3794.465	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 15	2104.06 hoursnanograms per milliliter (hng/mL) Standard Deviation 325.456	1673.48 hoursnanograms per milliliter (hng/mL) Standard Deviation 986.138	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 22	3634.33 hoursnanograms per milliliter (hng/mL) Standard Deviation 1591.770	5064.61 hoursnanograms per milliliter (hng/mL) Standard Deviation 4242.170	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 1	983.62 hoursnanograms per milliliter (hng/mL) Standard Deviation 501.515	2617.59 hoursnanograms per milliliter (hng/mL) Standard Deviation 2250.993	—	—	—	—
Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 15	3255.14 hoursnanograms per milliliter (hng/mL) Standard Deviation 513.699	2208.80 hoursnanograms per milliliter (hng/mL) Standard Deviation 775.572	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=7 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=7 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=10 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 22	5938.44 h*ng/mL Standard Deviation 2187.477	10100.42 h*ng/mL Standard Deviation 3889.091	5404.44 h*ng/mL Standard Deviation 4032.522	7085.47 h*ng/mL Standard Deviation 5196.199	—	—
Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 1	6842.88 h*ng/mL Standard Deviation 3251.994	5552.70 h*ng/mL Standard Deviation 4559.658	5149.10 h*ng/mL Standard Deviation 1922.588	7619.75 h*ng/mL Standard Deviation 3287.399	—	—
Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 22	7167.67 h*ng/mL Standard Deviation 4161.553	5668.59 h*ng/mL Standard Deviation 3536.016	3218.09 h*ng/mL Standard Deviation 1137.952	6801.02 h*ng/mL Standard Deviation 1841.871	—	—
Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 1	5674.83 h*ng/mL Standard Deviation 757.917	3248.39 h*ng/mL Standard Deviation 3165.907	2117.23 h*ng/mL Standard Deviation 970.849	5920.77 h*ng/mL Standard Deviation 2206.953	—	—
Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 1	2737.56 h*ng/mL Standard Deviation 1280.628	3440.08 h*ng/mL Standard Deviation 2274.864	2255.49 h*ng/mL Standard Deviation 1153.863	3140.29 h*ng/mL Standard Deviation 1139.965	—	—
Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 1	3409.44 h*ng/mL Standard Deviation 2059.973	1587.21 h*ng/mL Standard Deviation 1838.618	2381.90 h*ng/mL Standard Deviation 2767.733	2128.83 h*ng/mL Standard Deviation 1581.498	—	—

SECONDARY outcome

Timeframe: Cycle 1: predose, 0.5, 1.5, 4, 8 hours post-dose on Days 1 and 15, and predose, 1.5, 4, 8 hours post-dose on Day 8; Cycle 3: predose, 0.5, 1.5, 4, 8 hours post-dose on Day 1 and predose, 1.5, 4, 8 hours post-dose on Day 15 (each cycle = 28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=7 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 15	7280.65 h*ng/mL Standard Deviation 945.078	8024.00 h*ng/mL Standard Deviation 5036.125	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 1	4623.23 h*ng/mL Standard Deviation 2089.994	10627.09 h*ng/mL Standard Deviation 6520.082	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 15	6864.95 h*ng/mL Standard Deviation 1815.779	9072.05 h*ng/mL Standard Deviation 3529.268	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 1	8954.45 h*ng/mL Standard Deviation 1347.640	8497.84 h*ng/mL Standard Deviation 3213.996	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 8	6699.18 h*ng/mL Standard Deviation 1315.190	9437.55 h*ng/mL Standard Deviation 6036.801	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 1	5940.42 h*ng/mL Standard Deviation 2217.500	5128.38 h*ng/mL Standard Deviation 2307.490	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 8	7743.38 h*ng/mL Standard Deviation 1258.029	10646.90 h*ng/mL Standard Deviation 8177.450	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 15	4921.26 h*ng/mL Standard Deviation 741.691	4304.95 h*ng/mL Standard Deviation 2105.077	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 1	2315.46 h*ng/mL Standard Deviation 1568.487	6632.52 h*ng/mL Standard Deviation 6610.503	—	—	—	—
Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 15	6011.84 h*ng/mL Standard Deviation 429.313	6225.18 h*ng/mL Standard Deviation 2315.768	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Predose,0.5,1.5,4,8 hours post-dose (Days 1 and 15), predose,1.5,4,8 hours post-dose (Day 8), predose,1.5,4 hours post-dose (Day 22); Cycle 3: predose,0.5,1.5,4,8 hours post-dose (Day 1), predose,1.5,4,8 hours post-dose (Day 15) (Cycle=28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 1	3063.33 nanograms per milliliter (ng/mL) Standard Deviation 771.838	2020.63 nanograms per milliliter (ng/mL) Standard Deviation 1015.945	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 8	1656.67 nanograms per milliliter (ng/mL) Standard Deviation 568.624	2132.71 nanograms per milliliter (ng/mL) Standard Deviation 1346.859	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 15	2426.67 nanograms per milliliter (ng/mL) Standard Deviation 567.656	1956.29 nanograms per milliliter (ng/mL) Standard Deviation 1137.771	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 22	2037.00 nanograms per milliliter (ng/mL) Standard Deviation 1637.415	1528.96 nanograms per milliliter (ng/mL) Standard Deviation 910.236	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 1	1954.00 nanograms per milliliter (ng/mL) Standard Deviation 1119.459	3071.00 nanograms per milliliter (ng/mL) Standard Deviation 1928.848	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 15	1970.00 nanograms per milliliter (ng/mL) Standard Deviation 1244.508	2265.00 nanograms per milliliter (ng/mL) Standard Deviation 886.397	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 1	989.67 nanograms per milliliter (ng/mL) Standard Deviation 344.515	972.50 nanograms per milliliter (ng/mL) Standard Deviation 489.140	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 8	1193.33 nanograms per milliliter (ng/mL) Standard Deviation 222.336	1733.23 nanograms per milliliter (ng/mL) Standard Deviation 1184.636	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 15	868.00 nanograms per milliliter (ng/mL) Standard Deviation 117.051	915.86 nanograms per milliliter (ng/mL) Standard Deviation 390.840	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 22	1088.33 nanograms per milliliter (ng/mL) Standard Deviation 581.758	1658.68 nanograms per milliliter (ng/mL) Standard Deviation 1339.093	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 1	611.00 nanograms per milliliter (ng/mL) Standard Deviation 376.227	1343.60 nanograms per milliliter (ng/mL) Standard Deviation 1078.400	—	—	—	—
Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 15	1177.00 nanograms per milliliter (ng/mL) Standard Deviation 272.943	1148.50 nanograms per milliliter (ng/mL) Standard Deviation 458.398	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=8 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part B: Cmax of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 1	1077.38 ng/mL Standard Deviation 473.925	1070.71 ng/mL Standard Deviation 808.979	1190.00 ng/mL Standard Deviation 439.686	1320.00 ng/mL Standard Deviation 483.919	—	—
Part B: Cmax of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 22	1888.50 ng/mL Standard Deviation 668.598	2886.67 ng/mL Standard Deviation 915.394	1782.80 ng/mL Standard Deviation 1074.434	2289.10 ng/mL Standard Deviation 1414.128	—	—
Part B: Cmax of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 1	2839.5 ng/mL Standard Deviation 1293.43	2266.1 ng/mL Standard Deviation 1830.74	2331.3 ng/mL Standard Deviation 823.28	2850.0 ng/mL Standard Deviation 1413.87	—	—
Part B: Cmax of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 22	2786.3 ng/mL Standard Deviation 1591.66	2065.8 ng/mL Standard Deviation 1205.31	1327.0 ng/mL Standard Deviation 416.30	2891.0 ng/mL Standard Deviation 860.28	—	—
Part B: Cmax of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 1	2183.3 ng/mL Standard Deviation 496.42	1726.0 ng/mL Standard Deviation 1094.60	975.3 ng/mL Standard Deviation 179.70	2271.4 ng/mL Standard Deviation 954.80	—	—
Part B: Cmax of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 1	808.67 ng/mL Standard Deviation 748.505	738.00 ng/mL Standard Deviation 724.077	965.33 ng/mL Standard Deviation 982.152	891.29 ng/mL Standard Deviation 488.887	—	—

SECONDARY outcome

Timeframe: Cycle 1: predose on Days 3, 8, 15, 17 and 22; Cycle 3: predose on Days 1, 3, 15, 17; Cycle 6: predose on Day 1

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=6 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 8	387.00 ng/mL Standard Deviation 145.812	793.65 ng/mL Standard Deviation 953.516	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 15	33.30 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	6.39 ng/mL Standard Deviation 3.241	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 17	543.00 ng/mL Standard Deviation 154.182	531.93 ng/mL Standard Deviation 560.633	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 3	113.10 ng/mL Standard Deviation 31.892	169.50 ng/mL Standard Deviation 120.014	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 8	118.27 ng/mL Standard Deviation 30.751	173.35 ng/mL Standard Deviation 113.797	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 15	7.34 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	5.22 ng/mL Standard Deviation 2.844	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 17	99.37 ng/mL Standard Deviation 19.290	133.57 ng/mL Standard Deviation 86.239	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 22	83.53 ng/mL Standard Deviation 19.630	173.70 ng/mL Standard Deviation 135.079	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 1	10.20 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	4.72 ng/mL Standard Deviation 0.410	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 3	110.47 ng/mL Standard Deviation 13.808	97.20 ng/mL Standard Deviation 37.901	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 15	—	8.71 ng/mL Standard Deviation 6.640	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 17	118.00 ng/mL Standard Deviation 16.971	136.37 ng/mL Standard Deviation 81.772	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 6 Day 1	—	5.31 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 3	453.33 ng/mL Standard Deviation 180.059	620.10 ng/mL Standard Deviation 434.376	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 22	367.33 ng/mL Standard Deviation 289.588	805.78 ng/mL Standard Deviation 961.228	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 1	6.97 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	23.65 ng/mL Standard Deviation 27.655	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 3	443.67 ng/mL Standard Deviation 172.631	1157.50 ng/mL Standard Deviation 1304.612	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 15	—	13.55 ng/mL Standard Deviation 9.687	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 17	611.00 ng/mL Standard Deviation 322.441	639.67 ng/mL Standard Deviation 387.727	—	—	—	—
Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 6 Day 1	—	3.15 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: predose on Days 8 and 22; Cycle 3: predose on Day 1 (each cycle = 28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=8 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=7 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=10 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 22	150.29 ng/mL Standard Deviation 80.118	221.60 ng/mL Standard Deviation 140.039	130.92 ng/mL Standard Deviation 50.555	146.39 ng/mL Standard Deviation 50.852	—	—
Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 3 Day 1	3.24 ng/mL Standard Deviation 0.721	11.08 ng/mL Standard Deviation 12.056	3.50 ng/mL Standard Deviation 0.318	4.94 ng/mL Standard Deviation 2.137	—	—
Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 3 Day 1	2.84 ng/mL Standard Deviation 0.255	14.35 ng/mL Standard Deviation 11.809	—	10.30 ng/mL Standard Deviation 3.751	—	—
Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143: Cycle 1 Day 8	198.05 ng/mL Standard Deviation 143.494	167.20 ng/mL Standard Deviation 112.649	192.86 ng/mL Standard Deviation 130.457	143.39 ng/mL Standard Deviation 44.663	—	—
Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET: Cycle 1 Day 8	693.33 ng/mL Standard Deviation 983.009	1917.89 ng/mL Standard Deviation 1826.669	1005.20 ng/mL Standard Deviation 1150.843	1118.40 ng/mL Standard Deviation 710.330	—	—
Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1 Debio 1143-MET1: Cycle 1 Day 22	658.50 ng/mL Standard Deviation 557.846	2103.33 ng/mL Standard Deviation 1410.308	830.20 ng/mL Standard Deviation 827.444	1113.04 ng/mL Standard Deviation 811.962	—	—

SECONDARY outcome

Timeframe: Cycle 1: predose, 1.5, 8 hours post-dose on Day 15; Cycle 3: predose, 0.5, 1.5, 8 hours post-dose on Day 1 and predose, 1.5 hours post-dose on Day 15 (each cycle = 28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=7 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part A: Serum Trough Concentration of Nivolumab Cycle 1 Day 15	21366.67 ng/mL Standard Deviation 4808.673	22271.43 ng/mL Standard Deviation 7553.744	—	—	—	—
Part A: Serum Trough Concentration of Nivolumab Cycle 3 Day 1	43500.00 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	32700.00 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	—	—	—	—
Part A: Serum Trough Concentration of Nivolumab Cycle 3 Day 15	—	27100.00 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: predose, 1.5 hours post-dose on Day 15; Cycle 3: predose, 1.5 hours post-dose on Days 1 and Day 15; Cycle 6: predose on Day 1 (each cycle = 28 days)

Population: Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab n=8 Participants Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=7 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 Participants Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=10 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Part B: Serum Trough Concentration of Nivolumab Cycle 1 Day 15	21312.5 ng/mL Standard Deviation 2942.51	25414.3 ng/mL Standard Deviation 8766.68	33725.0 ng/mL Standard Deviation 17751.28	22332.0 ng/mL Standard Deviation 8864.61	—	—
Part B: Serum Trough Concentration of Nivolumab Cycle 3 Day 1	34100.0 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	40600.0 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	—	43866.7 ng/mL Standard Deviation 11670.08	—	—
Part B: Serum Trough Concentration of Nivolumab Cycle 3 Day 15	—	45400.0 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	—	58400.0 ng/mL Standard Deviation 10492.22	—	—
Part B: Serum Trough Concentration of Nivolumab Cycle 6 Day 1	—	40400.0 ng/mL Standard Deviation NA The standard deviation cannot be calculated for 1 participant.	—	—	—	—

SECONDARY outcome

The average of the time taken in days for PR is reported. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.

Outcome measures

Outcome measures
Measure	Part A - Debio 1143 150 mg + Nivolumab Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=2 Participants Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=1 Participants Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Parts A and B: Time to Response (TTR)	—	82 days Interval 56.0 to 108.0	—	—	—	52 days Interval 52.0 to 52.0

Adverse Events

Part A - Debio 1143 150 mg + Nivolumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A - Debio 1143 200 mg + Nivolumab

Serious events: 8 serious events

Other events: 8 other events

Deaths: 4 deaths

Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab

Serious events: 0 serious events

Other events: 8 other events

Deaths: 5 deaths

Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab

Serious events: 6 serious events

Other events: 8 other events

Deaths: 7 deaths

Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab

Serious events: 5 serious events

Other events: 8 other events

Deaths: 6 deaths

Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab

Serious events: 5 serious events

Other events: 11 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 participants at risk Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 participants at risk Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Disease progression	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Pyrexia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Fatigue	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Hepatobiliary disorders Bile duct stone	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Immune system disorders Drug hypersensitivity	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Cellulitis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Pneumonia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Sepsis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Disturbance in attention	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Other adverse events

Other adverse events
Measure	Part A - Debio 1143 150 mg + Nivolumab n=3 participants at risk Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part A - Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab n=8 participants at risk Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.	Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab n=11 participants at risk Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	36.4% 4/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Constipation	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	27.3% 3/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	27.3% 3/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Gingival pain	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Nausea	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Asthenia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Fatigue	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	75.0% 6/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Pyrexia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	27.3% 3/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Ear Infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Fungal Foot Infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Lip Infection	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Mucosal infection	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Oral candidiasis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Injury, poisoning and procedural complications Subdural haematoma	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	45.5% 5/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Amylase increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	36.4% 4/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Blood creatinine increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Lipase increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Weight decreased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Bell's palsy	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Dizziness	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Sciatica	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Leukoplakia	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	50.0% 4/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	27.3% 3/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	37.5% 3/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Cardiac disorders Angina pectoris	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Eye disorders Vision blurred	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Gastrointestinal disorders Oral pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Chills	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Facial pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Generalised oedema	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
General disorders Malaise	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Candida infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Gingivitis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Listeria encephalitis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Oral fungal infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Pseudomonas infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Skin infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Soft tissue infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Injury, poisoning and procedural complications VIth nerve injury	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Blood corticotrophin decreased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Blood creatine increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations C-reactive protein increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Cortisol decreased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Lymphocyte count decreased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Investigations Neutrophil count decreased	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	27.3% 3/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Dysgeusia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Headache	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Memory impairment	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Neuralgia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Somnolence	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	25.0% 2/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Nervous system disorders Vocal cord paralysis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Psychiatric disorders Agitation	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Psychiatric disorders Anxiety	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Psychiatric disorders Depression	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Psychiatric disorders Insomnia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Renal and urinary disorders Dysuria	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Renal and urinary disorders Haematuria	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Renal and urinary disorders Renal failure	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Reproductive system and breast disorders Vaginal fistula	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	18.2% 2/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Vascular disorders Lymphoedema	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Bronchitis	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	12.5% 1/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Infections and infestations Urinary tract infection	0.00% 0/3 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	0.00% 0/8 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.	9.1% 1/11 • From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B) Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.

Additional Information

Head Clinical Research & Development

Debiopharm International S.A.

Phone: 4121 321 01 11

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication or scientific communication related to this study can only take place once the agreement between the Sponsor and the Investigator has been reached.
Publication restrictions are in place

Restriction type: OTHER