Trial Outcomes & Findings for Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer (NCT NCT03414684)

Last Updated: 2025-09-29

Results Overview

Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years

Results posted on

2025-09-29

Participant Flow

The first patient was enrolled on February 12, 2018, and the last patient was enrolled on September 23, 2020.

96 patients were assessed for eligibility, and 18 were found to be ineligible. A total of 78 patients were enrolled and randomized.

Participant milestones

Participant milestones
Measure	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
First-course Treatment STARTED	39	39
First-course Treatment Started Treatment	37	38
First-course Treatment COMPLETED	0	0
First-course Treatment NOT COMPLETED	39	39
Crossover Treatment STARTED	0	18
Crossover Treatment COMPLETED	0	0
Crossover Treatment NOT COMPLETED	0	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
First-course Treatment Complete response	0	1
First-course Treatment Intercurrent illness	1	0
First-course Treatment Progressive Disease	31	32
First-course Treatment Adverse Event	1	2
First-course Treatment Physician Decision	0	1
First-course Treatment Withdrawal by Subject	0	1
First-course Treatment "Patient proceeded with chest wall excision"	1	0
First-course Treatment "Participant needed palliative radiation, which is not permitted on study"	0	1
First-course Treatment Still on treatment	3	0
First-course Treatment Never started protocol therapy	2	1
Crossover Treatment Progressive disease	0	12
Crossover Treatment Adverse Event	0	3
Crossover Treatment Physician Decision	0	1
Crossover Treatment Still on treatment	0	2

Baseline Characteristics

Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Carboplatin + Nivolumab n=37 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=38 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Total n=75 Participants Total of all reporting groups
Age, Continuous	59.1 years n=5 Participants	59.1 years n=7 Participants	59.1 years n=5 Participants
Age, Customized Age, years · <40	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized Age, years · 40-59	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized Age, years · >=60	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	36 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Germline BRCA Status gBRCA1 mutation	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Germline BRCA Status gBRCA2 mutation	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Germline BRCA Status Non-gBRCA1/2 carrier	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local Positive	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local Negative	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local Not done	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142 Positive (>=1% IC)	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142 Negative (<1% IC)	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Stromal tumor-infiltrating lymphocytes (sTILs) 0%	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Stromal tumor-infiltrating lymphocytes (sTILs) 1-9%	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Stromal tumor-infiltrating lymphocytes (sTILs) 10-49%	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Stromal tumor-infiltrating lymphocytes (sTILs) >=50%	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Stromal tumor-infiltrating lymphocytes (sTILs) Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-Fully active, able to carry on pre-disease performance without restriction	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1-Restricted in strenuous physical activity but able to perform work of a light or sedentary nature	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Inflammatory breast cancer Yes	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Inflammatory breast cancer No	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Prior anthracycline in neoadjuvant/adjuvant setting Yes	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Prior anthracycline in neoadjuvant/adjuvant setting No	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Prior taxane in neoadjuvant/adjuvant setting Yes	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Prior taxane in neoadjuvant/adjuvant setting No	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Prior platinum in neoadjuvant/adjuvant setting Yes	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Prior platinum in neoadjuvant/adjuvant setting No	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Number of lines of prior chemotherapy for advanced disease 0	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Number of lines of prior chemotherapy for advanced disease 1	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Baseline lactate dehydrogenase (LDH) <= Upper Limit of Normal	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Baseline lactate dehydrogenase (LDH) > Upper Limit of Normal	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Baseline lactate dehydrogenase (LDH) Unknown	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years

Population: The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.

Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=30 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=32 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Progression-free Survival	5.5 months Interval 4.4 to 19.2	4.2 months Interval 2.7 to 11.5

SECONDARY outcome

Timeframe: Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years

Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=30 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=32 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1	23.3 percent of patients Interval 9.9 to 42.3	25.0 percent of patients Interval 11.5 to 43.4

SECONDARY outcome

Population: First-course objective response rate by irRC was only evaluated in the 32 patients that received immunotherapy (on Arm A) in the ITT population. Because of this, statistical testing by arm was not performed.

Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=32 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Objective Response Rate by Immune-Related Response Criteria (irRC)	—	28.1 percent of patients Interval 13.7 to 46.7

SECONDARY outcome

Timeframe: Assessed from date of randomization until the date of death from any cause, up to 3.5 years

Defined as the time from randomization to death due to any cause, or censored at date last known alive

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=30 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=32 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Overall Survival	11.1 months Interval 8.2 to 24.4	16.8 months Interval 10.4 to Upper bound inestimable due to insufficient number of events

SECONDARY outcome

Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=30 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=32 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Clinical Benefit Rate	33.3 percent of patients Interval 17.3 to 52.8	34.4 percent of patients Interval 18.6 to 53.2

SECONDARY outcome

Timeframe: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years

Population: Duration of response was analyzed among the total 15 patients who achieved objective response in the ITT population.

Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=7 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=8 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Duration of Response	7.7 months Interval 2.7 to Upper bound inestimable due to insufficient number of events	19.3 months Interval 16.8 to Upper bound inestimable due to insufficient number of events

SECONDARY outcome

Timeframe: Assessed from randomization to the time of first response, up to 3.5 years

Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=30 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=32 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Time to Objective Response	11.2 months Interval 4.7 to Upper bound inestimable due to insufficient number of events	4.6 months Interval 4.0 to Upper bound inestimable due to insufficient number of events

SECONDARY outcome

Timeframe: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years

Population: A total of 24 patients were PD-L1-positive in the ITT population.

PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=11 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=13 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Progression-free Survival Among PD-L1-positive Patients	4.7 months Interval 1.6 to Upper bound inestimable due to insufficient number of events	8.3 months Interval 2.5 to Upper bound inestimable due to insufficient number of events

SECONDARY outcome

Population: A total of 24 patients were PD-L1-positive in the ITT population.

ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=11 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=13 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients	27.3 percent of patients Interval 6.0 to 61.0	23.1 percent of patients Interval 5.0 to 53.8

SECONDARY outcome

Population: A total of 13 patients were treated with immunotherapy (on Arm A) and were PD-L1-positive in the ITT population. Because first-course irORR was only assessed for patients on Arm A, no statistical testing by arm was performed.

ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=13 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Objective Response Rate by irRC Among PD-L1-positive Patients	—	30.8 percent of patients Interval 9.1 to 61.4

SECONDARY outcome

Timeframe: Assessed from date of randomization until the date of death from any cause, up to 3.5 years

Population: A total of 24 patients were PD-L1-positive in the ITT population.

OS defined as the time from randomization to death due to any cause, or censored at date last known alive. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=11 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=13 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Overall Survival Among PD-L1-positive Patients	10.7 months Interval 6.7 to Upper bound inestimable due to insufficient number of events	17.6 months Interval 4.9 to Upper bound inestimable due to insufficient number of events

SECONDARY outcome

Population: A total of 24 patients were PD-L1-positive in the ITT population.

CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=11 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=13 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Clinical Benefit Rate Among PD-L1-positive Patients	36.4 percent of patients Interval 10.9 to 69.2	30.8 percent of patients Interval 9.1 to 61.4

SECONDARY outcome

Timeframe: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years

Population: Duration of response was assessed only among the 6 PD-L1-positive patients in the ITT population who achieved objective response. Due to insufficient sample size, statistical testing by arm was not performed.

DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=3 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=3 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Duration of Response Among PD-L1-positive Patients	4.9 months Interval 2.0 to Upper bound inestimable due to insufficient sample size/number of events	16.8 months Bounds inestimable due to insufficient sample size/number of events

SECONDARY outcome

Timeframe: Assessed from randomization to the time of first response, up to 3.5 years

Population: A total of 24 patients were PD-L1-positive in the ITT population.

TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=11 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab n=13 Participants * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Time to Objective Response Among PD-L1-positive Patients	NA months Interval 3.0 to Median and upper bound inestimable due to insufficient number of responses	NA months Interval 3.4 to Median and upper bound inestimable due to insufficient number of responses

SECONDARY outcome

Timeframe: Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years

Population: 10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab

PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=10 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	4.1 months Interval 1.9 to Upper bound inestimable due to insufficient sample size / number of events	—

SECONDARY outcome

Timeframe: Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years

Population: 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=10 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	20.0 percent of patients Interval 2.5 to 55.6	—

SECONDARY outcome

Population: 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=10 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	20.0 percent of patients Interval 2.5 to 55.6	—

SECONDARY outcome

Population: 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab

CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=10 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	30.0 percent of patients Interval 6.7 to 65.2	—

SECONDARY outcome

Timeframe: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years

Population: 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab, and only 2 of these patients achieved objective response

DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter. Patients without events reported are censored at the last disease evaluation.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=2 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	1.81 months Interval 1.81 to Upper bound inestimable due to insufficient sample size	—

SECONDARY outcome

Timeframe: Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years

Population: 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab

TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=10 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	NA months Interval 3.5 to Median and upper bound inestimable due to insufficient number of responses	—

SECONDARY outcome

Timeframe: Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years

Population: 10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab

Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=10 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab	12.9 months Interval 6.4 to Upper bound inestimable due to insufficient number of events	—

SECONDARY outcome

Timeframe: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years

Population: A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.

PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=2 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Progression-free Survival Among BRCA-mutant Patients	4.74 months Interval 4.74 to Upper bound inestimable due to insufficient sample size/number of events	—

SECONDARY outcome

Population: A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.

ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \[i.e., "non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=2 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients	50.0 percent of patients Interval 1.3 to 98.7	—

SECONDARY outcome

Population: There were 0 patients treated with immunotherapy (on Arm A) and had BRCA1 or BRCA2 mutations in the ITT population.

ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters \[irSPD\] of 50% or greater) based on irRC. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until the date of death from any cause, assessed up to 3.5 years

Population: A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.

OS defined as the time from randomization to death due to any cause, or censored at date last known alive. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=2 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Overall Survival Among BRCA-mutant Patients	24.4 months Bounds inestimable due to insufficient sample size/number of events	—

SECONDARY outcome

Population: A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.

CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=2 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Clinical Benefit Rate Among BRCA-mutant Patients	50.0 percent of patients Interval 1.3 to 98.7	—

SECONDARY outcome

Timeframe: Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years

Population: Only 1 patient in the ITT cohort that had a BRCA1 or BRCA2 mutation also achieved objective response.

DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=1 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Duration of Response Among BRCA-mutant Patients	2.04 months Bounds inestimable due to insufficient sample size/number of events	—

SECONDARY outcome

Timeframe: Assessed from randomization to the time of first response, up to 3.5 years

Population: A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.

TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion n=2 Participants * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm A: Carboplatin + Nivolumab * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6
Time to Objective Response Among BRCA-mutant Patients	3.2 months Interval 3.2 to Upper bound inestimable due to insufficient sample size/number of events	—

Adverse Events

Arm A: Carboplatin + Nivolumab

Serious events: 10 serious events

Other events: 37 other events

Deaths: 24 deaths

Arm B: Carboplatin

Serious events: 11 serious events

Other events: 38 other events

Deaths: 17 deaths

Arm B: Carboplatin -- Crossover

Serious events: 6 serious events

Other events: 18 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Additional Information

Sara Tolaney, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-5743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm A: Carboplatin + Nivolumab n=37 participants at risk * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6	Arm B: Carboplatin n=38 participants at risk * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm B: Carboplatin -- Crossover n=18 participants at risk * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Blood and lymphatic system disorders Anemia	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Cardiac disorders Atrial fibrillation	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Colitis	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Diarrhea	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Fever	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Infusion related reaction	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Immune system disorders Allergic reaction	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Infections and infestations - Other, specify	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Joint infection	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Lung infection	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Sepsis	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Urinary tract infection	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Injury, poisoning and procedural complications Fall	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Blood bilirubin increased	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Neutrophil count decreased	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Platelet count decreased	8.1% 3/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations White blood cell decreased	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Nervous system disorders Cognitive disturbance	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Psychiatric disorders Confusion	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Reproductive system and breast disorders Breast pain	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Respiratory, thoracic and mediastinal disorders Dyspnea	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.3% 2/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Respiratory, thoracic and mediastinal disorders Hypoxia	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.3% 2/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Vascular disorders Hypotension	2.7% 1/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Cardiac disorders Pericardial effusion	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Vomiting	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Fatigue	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Pain	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.3% 2/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Upper respiratory infection	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	2.6% 1/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Enterocolitis	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Flu like symptoms	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.6% 1/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)

Other adverse events
Measure	Arm A: Carboplatin + Nivolumab n=37 participants at risk * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6	Arm B: Carboplatin n=38 participants at risk * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel	Arm B: Carboplatin -- Crossover n=18 participants at risk * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is AUC 6 * Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Blood and lymphatic system disorders Anemia	67.6% 25/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	52.6% 20/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	44.4% 8/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	8.1% 3/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	10.5% 4/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Cardiac disorders Atrial fibrillation	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.3% 2/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Ear and labyrinth disorders Tinnitus	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	10.5% 4/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Endocrine disorders Hypothyroidism	29.7% 11/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	7.9% 3/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Eye disorders Blurred vision	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Abdominal pain	8.1% 3/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	5.3% 2/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	16.7% 3/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Colitis	8.1% 3/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Constipation	48.6% 18/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	36.8% 14/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	22.2% 4/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Diarrhea	29.7% 11/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	18.4% 7/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	50.0% 9/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Gastroesophageal reflux disease	10.8% 4/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	7.9% 3/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Hemorrhoids	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Mucositis oral	13.5% 5/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Nausea	56.8% 21/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	68.4% 26/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	38.9% 7/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Gastrointestinal disorders Vomiting	13.5% 5/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	21.1% 8/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	16.7% 3/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Chills	10.8% 4/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Edema limbs	8.1% 3/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	13.2% 5/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Fatigue	75.7% 28/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	73.7% 28/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	61.1% 11/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Fever	13.5% 5/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	13.2% 5/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	27.8% 5/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Infusion related reaction	21.6% 8/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Localized edema	8.1% 3/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	16.7% 3/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Non-cardiac chest pain	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
General disorders Pain	27.0% 10/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	34.2% 13/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	22.2% 4/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Infections and infestations - Other, specify	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Lung infection	10.8% 4/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Sinusitis	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Skin infection	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	7.9% 3/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Upper respiratory infection	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	7.9% 3/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Urinary tract infection	10.8% 4/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Infections and infestations Vaginal infection	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Injury, poisoning and procedural complications Bruising	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Alanine aminotransferase increased	16.2% 6/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	7.9% 3/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Alkaline phosphatase increased	16.2% 6/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	7.9% 3/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Aspartate aminotransferase increased	18.9% 7/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	7.9% 3/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	16.7% 3/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Blood bilirubin increased	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Creatinine increased	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Investigations - Other, specify	5.4% 2/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	0.00% 0/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Lymphocyte count decreased	16.2% 6/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	13.2% 5/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	11.1% 2/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Neutrophil count decreased	54.1% 20/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	55.3% 21/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	38.9% 7/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
Investigations Platelet count decreased	78.4% 29/37 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	52.6% 20/38 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)	27.8% 5/18 • Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years. An SAE is any untoward medical occurrence that: * results in death * is life-threatening (i.e., participant was at risk of death at the time of the event) * requires hospitalization or prolongs existing hospitalization * results in persistent/significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)