Trial Outcomes & Findings for An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers (NCT NCT02869789)

Last Updated: 2023-06-15

Results Overview

Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1041 participants

Primary outcome timeframe

From first dose to 30 days post last dose (Up to approximately 27 months)

Results posted on

2023-06-15

Participant Flow

Analysis for the NSCLC special population cohort A1 is pre-specified as exploratory.

Participant milestones

Participant milestones
Measure	Cohort A First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort A1 First-line NSCLC special population: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Overall Study STARTED	391	198	395	57
Overall Study COMPLETED	56	16	30	12
Overall Study NOT COMPLETED	335	182	365	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort A1 First-line NSCLC special population: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Overall Study Disease progression	184	109	260	19
Overall Study Study drug toxicity	90	32	55	14
Overall Study Death	7	3	5	1
Overall Study Adverse Event unrelated to study drug	30	18	21	6
Overall Study Participant request to discontinue study treatment	10	5	5	3
Overall Study Withdrawal by Subject	5	2	7	2
Overall Study Lost to Follow-up	0	0	2	0
Overall Study Maximum clinical benefit	5	2	1	0
Overall Study Poor/Non-compliance	0	2	1	0
Overall Study Participant no longer meets study criteria	0	1	1	0
Overall Study Administrative reason by sponsor	0	0	1	0
Overall Study Other reasons	4	8	6	0

Baseline Characteristics

An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=391 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort A1 n=198 Participants First-line NSCLC special population: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=395 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=57 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Total n=1041 Participants Total of all reporting groups
Age, Customized < 65 years old	183 Participants n=5 Participants	81 Participants n=7 Participants	200 Participants n=5 Participants	24 Participants n=4 Participants	488 Participants n=21 Participants
Age, Customized >= 65 and < 85 years old	206 Participants n=5 Participants	115 Participants n=7 Participants	195 Participants n=5 Participants	30 Participants n=4 Participants	546 Participants n=21 Participants
Age, Customized >= 85 years old	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	71 Participants n=7 Participants	128 Participants n=5 Participants	29 Participants n=4 Participants	383 Participants n=21 Participants
Sex: Female, Male Male	236 Participants n=5 Participants	127 Participants n=7 Participants	267 Participants n=5 Participants	28 Participants n=4 Participants	658 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	3 Participants n=4 Participants	38 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	185 Participants n=5 Participants	78 Participants n=7 Participants	175 Participants n=5 Participants	54 Participants n=4 Participants	492 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	196 Participants n=5 Participants	107 Participants n=7 Participants	208 Participants n=5 Participants	0 Participants n=4 Participants	511 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	22 Participants n=21 Participants
Race (NIH/OMB) White	379 Participants n=5 Participants	194 Participants n=7 Participants	382 Participants n=5 Participants	47 Participants n=4 Participants	1002 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to approximately 27 months)

Population: All treated participants as pre-specified in Cohort A, B, and C

Outcome measures

Outcome measures
Measure	Cohort A n=391 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=395 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=57 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Gastrointestinal AEs grade 3-4	19 Participants	15 Participants	4 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Gastrointestinal AEs grade 5	0 Participants	0 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Hepatic AEs grade 3-4	25 Participants	17 Participants	3 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Hepatic AEs grade 5	0 Participants	0 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Pulmonary AEs grade 3-4	18 Participants	11 Participants	2 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Pulmonary AEs grade 5	0 Participants	1 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Renal AEs grade 3-4	2 Participants	1 Participants	1 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Skin AEs grade 3-4	14 Participants	9 Participants	2 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Skin AEs grade 5	0 Participants	0 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Endocrine AEs grade 3-4	16 Participants	11 Participants	2 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Endocrine AEs grade 5	0 Participants	0 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Hypersensitivity/Infusion Reaction grade 3-4	6 Participants	3 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Hypersensitivity/Infusion Reaction grade 5	0 Participants	0 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) Renal AEs grade 5	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days post last dose (Up to approximately 29 months)

Population: All treated participants as pre-specified in Cohort A, B, and C

imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death

Outcome measures

Outcome measures
Measure	Cohort A n=391 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=395 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=57 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Pneumonitis grade 3-4	20 Participants	14 Participants	3 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Diarrhea/Colitis grade 3-4	19 Participants	15 Participants	3 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Hepatitis grade 3-4	18 Participants	13 Participants	1 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Adrenal Insufficiency grade 3-4	5 Participants	4 Participants	1 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Hypothyroidism/Thyroiditis grade 3-4	2 Participants	2 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Hypothyroidism grade 3-4	1 Participants	1 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Thyroiditis grade 3-4	1 Participants	1 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Diabetes Mellitus grade 3-4	1 Participants	0 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Nephritis and Renal Dysfunction grade 3-4	2 Participants	1 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Rash grade 3-4	14 Participants	8 Participants	1 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Hypersensitivity grade 3-4	4 Participants	2 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Hyperthyroidism grade 3-4	0 Participants	2 Participants	0 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Hypophysitis grade 3-4	3 Participants	1 Participants	1 Participants
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) Any category imAEs grade 5	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)

Population: All treated participants as pre-specified in Cohort A, B, and C

PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Cohort A n=391 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=395 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=57 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Progression Free Survival (PFS)	5.75 Months Interval 4.5 to 7.62	3.91 Months Interval 2.89 to 4.24	11.10 Months Interval 6.47 to 18.4

SECONDARY outcome

Timeframe: From first dosing date to the date of death (Up to approximately 67 months)

Population: All treated participants as pre-specified in Cohort A, B, and C

OS is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive.

Outcome measures

Outcome measures
Measure	Cohort A n=391 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=395 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=57 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Overall Survival (OS)	16.76 Months Interval 14.65 to 22.41	10.45 Months Interval 8.84 to 12.22	26.09 Months Interval 21.85 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: From first dosing date up to approximately 67 months

Population: All treated participants as pre-specified in Cohort A, B, and C

ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Cohort A n=391 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=395 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=57 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Objective Response Rate (ORR)	37.3 Percentage of participants Interval 32.5 to 42.3	22.8 Percentage of participants Interval 18.7 to 27.2	45.6 Percentage of participants Interval 32.4 to 59.3

SECONDARY outcome

Timeframe: From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)

Population: All treated participants with confirmed CR or PR as pre-specified in Cohort A, B, and C

DoR is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression per RECIST 1.1, or death due to any cause, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Cohort A n=146 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=90 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=26 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Duration of Response (DoR)	27.56 Months Interval 20.4 to 36.04	13.01 Months Interval 10.12 to 19.29	26.05 Months Interval 12.22 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)

Population: All treated participants who have an assessment at baseline and at least 1 follow-up assessment as pre-specified in Cohort A, B, and C

FACT-L is a quality-of-life questionnaire which includes Lung Cancer Subscale (LCS) that assesses the treatment impact on lung cancer related symptoms in 5 domains: Physical, social/family, emotional, and functional well-being using a 5-point scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) added to obtain total score. The ranges of possible total scores are 0-136 for the FACT-L with a higher score representing better quality of life, improved symptomatology and enhanced physical/functional outcomes. According to Functional Assessment of Chronic Illness Therapy scoring guidelines, in the event of missing responses for some of the questions, scores will be prorated using the average of the other answers in that scale. Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.

Outcome measures

Outcome measures
Measure	Cohort A n=364 Participants First-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort B n=365 Participants Second-line NSCLC: Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first	Cohort C n=57 Participants First-line NSCLC high tumor mutational burden (H-TMB \>= 10 mutations/MB): Nivolumab 240 mg IV Q2W + Ipilimumab 1 mg/kg IV Q6W, starting on Day 1, until progression, unacceptable toxicity, withdrawal of consent, 24 months of treatment from the first dose, or the study ends, whichever occurs first
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) Baseline	94.89 Units on a Scale Standard Deviation 19.33	91.20 Units on a Scale Standard Deviation 18.45	93.96 Units on a Scale Standard Deviation 17.28
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) Survival Follow-up visit 18	-43.33 Units on a Scale Standard Deviation NA Insufficient number of participants with events	—	—
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) Treatment Week 6	-0.84 Units on a Scale Standard Deviation 13.82	-0.30 Units on a Scale Standard Deviation 14.87	2.72 Units on a Scale Standard Deviation 12.95
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) Survival Follow-up visit 6	14.68 Units on a Scale Standard Deviation 13.58	3.81 Units on a Scale Standard Deviation 18.59	12.42 Units on a Scale Standard Deviation 24.87
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) Survival Follow-up visit 16	5.28 Units on a Scale Standard Deviation 28.19	-18.00 Units on a Scale Standard Deviation NA Insufficient number of participants with events	—

Adverse Events

Cohort A

Serious events: 264 serious events

Other events: 362 other events

Deaths: 294 deaths

Cohort A1

Serious events: 149 serious events

Other events: 174 other events

Deaths: 166 deaths

Cohort B

Serious events: 282 serious events

Other events: 346 other events

Deaths: 334 deaths

Cohort C

Serious events: 42 serious events

Other events: 56 other events

Deaths: 32 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