Trial Outcomes & Findings for A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney (NCT NCT03138512)

Last Updated: 2024-12-18

Results Overview

Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1641 participants

Primary outcome timeframe

From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

Results posted on

2024-12-18

Participant Flow

Part A and B participants are separately randomized and treated.

Participant milestones

Participant milestones
Measure	Treatment Part A: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
Randomization STARTED	405	411	206	208	411
Randomization COMPLETED	404	407	204	207	408
Randomization NOT COMPLETED	1	4	2	1	3
Treatment Part A STARTED	404	407	0	0	0
Treatment Part A COMPLETED	229	360	0	0	0
Treatment Part A NOT COMPLETED	175	47	0	0	0
Treatment Part B STARTED	0	0	204	207	408
Treatment Part B COMPLETED	0	0	118	182	327
Treatment Part B NOT COMPLETED	0	0	86	25	81

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Part A: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
Randomization Participants withdrew consent	0	1	1	0	0
Randomization Participant no longer meets study criteria	0	3	1	1	3
Randomization Other reasons	1	0	0	0	0
Treatment Part A Disease recurrence	10	20	0	0	0
Treatment Part A Study Drug Toxicity	132	5	0	0	0
Treatment Part A Death	1	0	0	0	0
Treatment Part A Adverse event unrelated to study drug	9	4	0	0	0
Treatment Part A Participant request to discontinue treatment	9	4	0	0	0
Treatment Part A Participant withdrew consent	2	4	0	0	0
Treatment Part A Lost to Follow-up	0	1	0	0	0
Treatment Part A Poor/non-compliance	1	0	0	0	0
Treatment Part A Pregnancy	0	1	0	0	0
Treatment Part A Other reasons	11	8	0	0	0
Treatment Part B Disease recurrence	0	0	6	12	10
Treatment Part B Study drug toxicity	0	0	63	3	45
Treatment Part B Death	0	0	1	0	0
Treatment Part B Adverse event unrelated to study drug	0	0	5	2	12
Treatment Part B Participants request to discontinue study treatment	0	0	6	4	6
Treatment Part B Participant withdrew consent	0	0	1	1	2
Treatment Part B Lost to Follow-up	0	0	0	1	0
Treatment Part B Poor/non-compliance	0	0	1	1	1
Treatment Part B Other reasons	0	0	3	1	5

Baseline Characteristics

Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Part A: Nivo + Ipi n=405 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=411 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi n=206 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo n=208 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo n=411 Participants Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).	Total n=1641 Participants Total of all reporting groups
Age, Customized < 65	293 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	301 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	132 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	137 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	279 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1142 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Age, Customized >= 65 AND < 75	93 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	91 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	64 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	60 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	108 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	416 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Age, Customized >= 75 AND < 85	19 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	19 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	10 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	11 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	23 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	82 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Age, Customized >= 85	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Sex: Female, Male Female	119 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	117 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	59 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	67 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	106 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	468 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Sex: Female, Male Male	286 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	294 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	147 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	141 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	305 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1173 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	44 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	26 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	34 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	67 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	212 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Ethnicity (NIH/OMB) Not Hispanic or Latino	189 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	197 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	93 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	79 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	157 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	715 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Ethnicity (NIH/OMB) Unknown or Not Reported	175 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	170 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	87 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	95 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	187 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	714 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	3 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	5 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	3 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	14 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	25 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Race (NIH/OMB) Asian	93 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	65 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	20 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	26 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	50 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	254 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	6 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	4 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	14 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Race (NIH/OMB) White	303 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	322 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	173 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	169 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	331 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	1298 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	0 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	14 Participants n=7 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	8 Participants n=5 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	9 Participants n=4 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	12 Participants n=21 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.	49 Participants n=8 Participants • Part A and B are separately treated participants. The combined number of participants from Part A and B are equal to the total number randomized to this study.

PRIMARY outcome

Timeframe: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

Population: All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms) and Treatment Part B (Placebo and Nivo Arms). The Nivo + Ipi Arm was prespecified to be excluded from the endpoint objective for Treatment Part B.

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=405 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=411 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo n=208 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo n=411 Participants Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
Disease-Free Survival (DFS) by BICR - Treatment Part A and B	NA Months Insufficient number of participants with events	NA Months Interval 65.58 to Insufficient number of participants with events	—	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events

SECONDARY outcome

Timeframe: From randomization to the date of death (up to approximately 72 months)

Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=405 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=411 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo n=208 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo n=411 Participants Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
Overall Survival (OS) - Treatment Part A and B	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	—	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events

SECONDARY outcome

Timeframe: At 5 years

Population: All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms). Data was not collected for Treatment Part B.

Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years.

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=405 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=411 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
Overall Survival (OS) Rate (5 Years) - Treatment Part A and B	85.0 Percent of participants Interval 80.8 to 88.3	87.2 Percent of participants Interval 82.8 to 90.5	—	—	—

SECONDARY outcome

Timeframe: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

Population: All randomized Nivo + Ipi and Nivo participants in Treatment Part B. Prespecified to be collected for Treatment Part B only. The Placebo Arm was prespecified to be excluded from the endpoint objective.

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=206 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=411 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B	NA Months Interval 36.17 to Insufficient number of participants with events	NA Months Insufficient number of participants with events	—	—	—

SECONDARY outcome

Timeframe: From randomization to the date of death (up to approximately 72 months)

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=206 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=411 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	—	—	—

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (up to approximately 40 weeks)

Population: All Treated Participants in Treatment Part A

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=404 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=407 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A Any Grade AE	392 Participants	362 Participants	—	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A Grade 3-4 AE	154 Participants	44 Participants	—	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A Grade 5 AE	1 Participants	0 Participants	—	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A Any Grade Drug-Related AE	359 Participants	230 Participants	—	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A Grade 3-4 Drug-Related AE	114 Participants	8 Participants	—	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A Grade 5 Drug-Related AE	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (up to approximately 40 weeks)

Population: All Treated Participants in Treatment Part B

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=204 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=207 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi n=408 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B Any Grade AE	193 Participants	182 Participants	362 Participants	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B Grade 3-4 AE	59 Participants	31 Participants	70 Participants	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B Grade 5 AE	1 Participants	1 Participants	0 Participants	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B Any Grade Drug-Related AE	173 Participants	107 Participants	297 Participants	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B Grade 3-4 Drug-Related AE	41 Participants	4 Participants	36 Participants	—	—
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B Grade 5 Drug-Related AE	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From first dose to 100 days post last dose (up to approximately 50 weeks)

Population: All Treated Participants in Treatment Part A

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=404 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=407 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A Any Grade AE	393 Participants	365 Participants	—	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A Grade 3-4 AE	167 Participants	52 Participants	—	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A Grade 5 AE	4 Participants	1 Participants	—	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A Any Grade Drug-Related AE	361 Participants	230 Participants	—	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A Grade 3-4 Drug-Related AE	128 Participants	9 Participants	—	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A Grade 5 Drug-Related AE	2 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose to 100 days post last dose (up to approximately 50 weeks)

Population: All Treated Participants in Treatment Part B

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=204 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=207 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi n=408 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B Grade 5 AE	5 Participants	2 Participants	2 Participants	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B Any Grade Drug-Related AE	175 Participants	108 Participants	300 Participants	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B Grade 3-4 Drug-Related AE	46 Participants	5 Participants	46 Participants	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B Grade 5 Drug-Related AE	0 Participants	0 Participants	0 Participants	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B Any Grade AE	196 Participants	182 Participants	367 Participants	—	—
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B Grade 3-4 AE	68 Participants	32 Participants	85 Participants	—	—

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (up to approximately 40 weeks)

Population: All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=398 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=404 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HEMOGLOBIN	1 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A PLATELET COUNT	1 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A LEUKOCYTES, LOCAL LAB	0 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A LYMPHOCYTES (ABSOLUTE), TOTAL	6 Participants	3 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A ABSOLUTE NEUTROPHIL COUNT	2 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A ALKALINE PHOSPHATASE, LOCAL LAB	3 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A ASPARTATE AMINOTRANSFERASE, LOCAL LAB	14 Participants	3 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A ALANINE AMINOTRANSFERASE, LOCAL LAB	16 Participants	5 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A BILIRUBIN, TOTAL, LOCAL LAB	1 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A CREATININE, LOCAL LAB	1 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPERNATREMIA	0 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPONATREMIA	28 Participants	7 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPERKALEMIA	6 Participants	5 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPOKALEMIA	3 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPERCALCEMIA	3 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPOCALCEMIA	1 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPERMAGNESEMIA	1 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPOMAGNESEMIA	1 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPERGLYCEMIA	6 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A HYPOGLYCEMIA	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (up to approximately 40 weeks)

Population: All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=201 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=205 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi n=406 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HEMOGLOBIN	0 Participants	3 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B PLATELET COUNT	0 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B LEUKOCYTES, LOCAL LAB	0 Participants	0 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B LYMPHOCYTES (ABSOLUTE), TOTAL	3 Participants	1 Participants	4 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B ABSOLUTE NEUTROPHIL COUNT	0 Participants	0 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B ALKALINE PHOSPHATASE, LOCAL LAB	1 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B ASPARTATE AMINOTRANSFERASE, LOCAL LAB	4 Participants	4 Participants	5 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B ALANINE AMINOTRANSFERASE, LOCAL LAB	7 Participants	3 Participants	8 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B BILIRUBIN, TOTAL, LOCAL LAB	0 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B CREATININE, LOCAL LAB	3 Participants	0 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPERNATREMIA	0 Participants	0 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPONATREMIA	11 Participants	1 Participants	9 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPERKALEMIA	1 Participants	2 Participants	2 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPOKALEMIA	1 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPERCALCEMIA	1 Participants	0 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPOCALCEMIA	0 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPERMAGNESEMIA	2 Participants	2 Participants	3 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPOMAGNESEMIA	0 Participants	1 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPERGLYCEMIA	3 Participants	1 Participants	3 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B HYPOGLYCEMIA	0 Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From first dose to 100 days post last dose (up to approximately 50 weeks)

Population: All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=401 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=406 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HEMOGLOBIN	1 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A PLATELET COUNT	1 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A LEUKOCYTES, LOCAL LAB	0 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A LYMPHOCYTES (ABSOLUTE), TOTAL	11 Participants	3 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A ABSOLUTE NEUTROPHIL COUNT	2 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A ALKALINE PHOSPHATASE, LOCAL LAB	5 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A ASPARTATE AMINOTRANSFERASE, LOCAL LAB	17 Participants	3 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A ALANINE AMINOTRANSFERASE, LOCAL LAB	20 Participants	6 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A BILIRUBIN, TOTAL, LOCAL LAB	3 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A CREATININE, LOCAL LAB	4 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPERNATREMIA	0 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPONATREMIA	30 Participants	7 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPERKALEMIA	6 Participants	5 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPOKALEMIA	5 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPERCALCEMIA	3 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPOCALCEMIA	1 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPERMAGNESEMIA	1 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPOMAGNESEMIA	1 Participants	0 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPERGLYCEMIA	7 Participants	1 Participants	—	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A HYPOGLYCEMIA	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose to 100 days post last dose (up to approximately 50 weeks)

Population: All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Outcome measures

Outcome measures
Measure	Treatment Part A: Nivo + Ipi n=203 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part A: Placebo n=205 Participants Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo + Ipi n=407 Participants Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HEMOGLOBIN	2 Participants	3 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B PLATELET COUNT	0 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B LEUKOCYTES, LOCAL LAB	0 Participants	0 Participants	2 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B LYMPHOCYTES (ABSOLUTE), TOTAL	3 Participants	2 Participants	7 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B ABSOLUTE NEUTROPHIL COUNT	0 Participants	0 Participants	2 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B ALKALINE PHOSPHATASE, LOCAL LAB	2 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B ASPARTATE AMINOTRANSFERASE, LOCAL LAB	6 Participants	4 Participants	6 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B ALANINE AMINOTRANSFERASE, LOCAL LAB	9 Participants	3 Participants	10 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B BILIRUBIN, TOTAL, LOCAL LAB	0 Participants	1 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B CREATININE, LOCAL LAB	4 Participants	0 Participants	3 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPERNATREMIA	0 Participants	0 Participants	0 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPONATREMIA	12 Participants	1 Participants	13 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPERKALEMIA	1 Participants	2 Participants	4 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPOKALEMIA	1 Participants	2 Participants	2 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPERCALCEMIA	1 Participants	0 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPOCALCEMIA	0 Participants	1 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPERMAGNESEMIA	3 Participants	2 Participants	3 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPOMAGNESEMIA	0 Participants	1 Participants	1 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPERGLYCEMIA	3 Participants	1 Participants	4 Participants	—	—
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B HYPOGLYCEMIA	0 Participants	0 Participants	1 Participants	—	—

Adverse Events

Treatment Part A and B: Nivo + Ipi

Serious events: 196 serious events

Other events: 544 other events

Deaths: 65 deaths

Treatment Part A and B: Placebo

Serious events: 49 serious events

Other events: 469 other events

Deaths: 55 deaths

Treatment Part B: Nivo

Serious events: 56 serious events

Other events: 325 other events

Deaths: 22 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER