RELATIVITY-047: A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03470922
• Collaborator: (none)
• Enrollment: 714
• Locations: 127
• Arms: 2
• Anticipated Duration (Months): 67.6
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Biological: Relatlimab; Biological: Nivolumab	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 714 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
• Actual Study Start Date: Apr 11, 2018
• Actual Primary Completion Date: Jan 25, 2021
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Relatlimab + Nivolumab Combination	Biological: Relatlimab; Specified dose on specified day; Biological: Nivolumab; Specified dose on specified days
Experimental: Arm B: Nivolumab Monotherapy	Biological: Nivolumab; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [From randomization to date of first documented tumor progression or death (up to approximately 33 months)]

   Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

Secondary Outcome Measures

1. Overall Survival (OS) [From randomization to the date of death (up to approximately 3 years)]

   Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").

2. Overall Response Rate (ORR) [From randomization up to approximately 3 years]

   Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).

Other Outcome Measures

1. The Number of Participants Experiencing Adverse Events (AEs) [From first dose to 30 days after last dose of study therapy (up to approximately 33 months)]

   The number of participants experiencing adverse events (AEs). 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.

2. The Number of Participants Experiencing Serious Adverse Events (SAEs) [From first dose to 30 days after last dose of study therapy (up to approximately 33 months)]

   The number of participants experiencing serious adverse events (SAEs). A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

3. The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [From first dose to 30 days after last dose of study therapy (up to approximately 33 months)]

   The number of participants experiencing adverse events (AEs) leading to discontinuation. 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.

4. The Number of Participant Deaths in the Study [From first dose up to approximately 33 months]

   The number of participant deaths in the study.

5. The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests [From first dose to 30 days after last dose of study therapy (up to approximately 33 months)]

   The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.

6. The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests [From first dose to 30 days after last dose of study therapy (up to approximately 33 months)]

   The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system

• Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma

• Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses

Exclusion Criteria:

• Participants must not have active brain metastases or leptomeningeal metastases

• Participants must not have uveal melanoma

• Participants must not have an active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Cancer Center	Tucson	Arizona	United States	85724
2	UCLA Hematology/Oncology Clinic	Los Angeles	California	United States	90095
3	Coastal Integrative Cancer Care	San Luis Obispo	California	United States	93401
4	Sansum Santa Barbara Medical Foundation Clinic	Santa Barbara	California	United States	93105
5	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
6	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
7	Orlando Health, Inc	Orlando	Florida	United States	32806
8	Moffitt Mckinley Outpatient Center	Tampa	Florida	United States	33612
9	Northside Hospital	Atlanta	Georgia	United States	30342
10	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
11	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46804
12	H & J Weinberg Can Int @ Franklin Square	Baltimore	Maryland	United States	21237
13	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland	United States	21287
14	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
15	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
16	University of Michigan	Ann Arbor	Michigan	United States	48109
17	Virginia Piper Cancer Institute	Minneapolis	Minnesota	United States	55407
18	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
19	Carolinas Healthcare System	Charlotte	North Carolina	United States	28204
20	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
21	Texas Oncology Sammons Cancer Center	Dallas	Texas	United States	75246
22	MD Anderson Cancer Center	Houston	Texas	United States	77030
23	Instituto Alexander Fleming	Capital Federal	Buenos Aires	Argentina	1426
24	Local Institution	Buenos Aires	Distrito Federal	Argentina	1121
25	Hospital Britanico De Buenos Aires	Capital Federal	Distrito Federal	Argentina	C1280AEB
26	Hospital Italiano De Buenos Aires	Buenos Aires		Argentina	1199
27	Local Institution	Buenos Aires		Argentina	4102-4200
28	Melanoma Institute Australia	North Sydney	New South Wales	Australia	2060
29	Calvary Mater Newcastle	Waratah	New South Wales	Australia	2298
30	Greenslopes Private Hospital	Greenslopes	Queensland	Australia	4120
31	Local Institution	Southport	Queensland	Australia	4215
32	Flinders Medical Centre	Bedford Park	South Australia	Australia	5042
33	Local Institution	Murdoch	Western Australia	Australia	6150
34	Local Institution	Graz		Austria	8036
35	Local Institution	Salzburg		Austria	5020
36	Local Institution	Wien		Austria	1090
37	Local Institution	Brussels		Belgium	1090
38	Local Institution	Bruxelles		Belgium	1200
39	Local Institution	Gent		Belgium	9000
40	Local Institution	Belo Horizonte	Minas Gerais	Brazil	30130-090
41	Local Institution	Porto Alegre	RIO Grande DO SUL	Brazil	90035-903
42	Local Institution	Porto Alegre	RIO Grande DO SUL	Brazil	91350-200
43	Local Institution	Santa Cruz do Sul	RIO Grande DO SUL	Brazil	96810-110
44	Local Institution	São Paulo	SAO Paulo	Brazil	01246-000
45	Local Institution	São Paulo	SAO Paulo	Brazil	05651-901
46	Local Institution	Rio De Janiro		Brazil	20220-410
47	Local Institution	Sao Paulo		Brazil	01509-900
48	Local Institution	Halifax	Nova Scotia	Canada	B3H 2Y9
49	Local Institution	Ottawa	Ontario	Canada	K1H 8L6
50	Local Institution	Toronto	Ontario	Canada	M5G 2M9
51	Local Institution	Montreal	Quebec	Canada	H3T 1E2
52	MUHC - Glen Site	Montreal	Quebec	Canada	H4A 3J1
53	Fundacion Arturo Lopez Perez	Santiago	Metropolitana	Chile
54	Local Institution	Bogota		Colombia	110321
55	Local Institution	Medellin		Colombia	050030
56	Local Institution	Aarhus N		Denmark	8200
57	Local Institution	Herlev		Denmark	2730
58	Local Institution	Odense		Denmark	5000
59	Local Institution	Helsinki		Finland	00290
60	Local Institution	Oulu		Finland	90230
61	Local Institution	Tampere		Finland	33521
62	Local Institution	Turku		Finland	20520
63	Chu D'Amiens - Hopital Nord	Amiens Cedex 1		France	80054
64	Hopital Saint Andre	Bordeaux Cedex		France	33075
65	Hopital Claude Huriez	Lille		France	59000
66	Hopital De La Timone	Marseille Cedex 5		France	13385
67	Hopital Saint Louis	Paris		France	75010
68	Centre Hospitalier Lyon Sud	Pierre-Benite		France	69310
69	Local Institution	Poitiers		France	86000
70	Local Institution	Rennes Cedex		France	35042
71	Elbe Klinikum Buxtehude	Buxtehude		Germany	21614
72	Local Institution	Erfurt		Germany	99089
73	Local Institution	Essen		Germany	45147
74	Medizinische Hochschule Hannover (Hannover Medical School)	Hannover		Germany	30625
75	Local Institution	Heidelberg		Germany	69120
76	Local Institution	Homburg / Saar		Germany	66421
77	Local Institution	Koeln		Germany	50937
78	Local Institution	Lubeck		Germany	23538
79	Local Institution	Mannheim		Germany	68167
80	Local Institution	Munich		Germany	81675
81	Local Institution	Quedlinburg		Germany	6484
82	Local Institution	Tuebingen		Germany	72076
83	Univ. Klinikum Wuerzburg	Wuerzburg		Germany	97080
84	Laiko General Hospital Of Athens	Athens		Greece	11526
85	BioClinic Thessaloniki	Thessaloniki		Greece	54622
86	Local Institution	Haifa		Israel	3109601
87	Local Institution	Jerusalem		Israel	91120
88	Local Institution	Ramat-gan		Israel	52621
89	ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII	Bergamo		Italy	24127
90	IRCCS Istituto Nazionale Tumori Milano	Milano		Italy	20133
91	Istituto Nazionale Tumori Fondazione Pascale	Napoli		Italy	80131
92	Istituto Oncologico Veneto IOV	Padova		Italy	35128
93	AOUS - Policlinico S.Maria Alle Scotte	Siena		Italy	53100
94	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino		Italy	10126
95	Local Institution	Zapopan	Jalisco	Mexico	45070
96	Local Institution	Monterrey	Nuevo LEON	Mexico	64060
97	Local Institution	Benito Juarez	Quintana ROO	Mexico	77500
98	Local Institution	Merida	Yucatan	Mexico	97134
99	Local Institution	Veracruz		Mexico	91900
100	Local Institution	Dunedin		New Zealand	9012
101	Local Institution	Hamilton		New Zealand	3240
102	Local Institution	Tauranga		New Zealand	3112
103	Local Institution	Oslo		Norway	0310
104	Oddzial Onkologii Klinicznej i Doswiadczalnej	Poznan		Poland	60-780
105	Local Institution	Warszawa		Poland	02-781
106	Local Institution	Bucharest		Romania	 022328
107	Local Institution	Cluj-Napoca		Romania	400015
108	Local Institution	Craiova		Romania	200347
109	Local Institution	Lasi		Romania	700483
110	Local Institution	Krasnodar		Russian Federation	350040
111	Local Institution	Krasnoyarsk		Russian Federation	660133
112	Local Institution	Moscow		Russian Federation	115478
113	Comp. Hosp. Univ. A Coruna	A Coruña		Spain	15006
114	H. Univ. Vall dHebron	Barcelona		Spain	08035
115	Hospital Clinic I Provincial	Barcelona		Spain	08036
116	Hospital Universitario Ramon Y Cajal	Madrid		Spain	28034
117	Onkologikoa Of San Sebastian	San Sabastian Gipuzkoa		Spain	20014
118	Hosp Univ Virgen Macarena	Sevilla		Spain	41009
119	Local Institution	Goteborg		Sweden	413 45
120	Local Institution	Lund		Sweden	221 85
121	Local Institution	Solna		Sweden	171 64
122	Local Institution	Uppsala		Sweden	751 85
123	Local Institution	Bristol	Avon	United Kingdom	BS2 8ED
124	Local Institution	Glasgow	Dumfries & Galloway	United Kingdom	G12 0YN
125	Local Institution	Swansea	Glamorgan	United Kingdom	SA2 8QA
126	Local Institution	London	Greater London	United Kingdom	SE1 9RT
127	Local Institution	Inverness	Inverness-shire	United Kingdom	IV2 3UJ

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol - Nov 23, 2020
• Statistical Analysis Plan - Oct 25, 2021

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03470922
• Other Study ID Numbers: CA224-047; 2017-003583-12
• First Posted: Mar 20, 2018
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Cancer; Advanced Cancer
• Additional relevant MeSH terms: Melanoma; Nivolumab

Study Results

Participant Flow

Pre-assignment Detail	714 Participants were randomized and received study treatment

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Period Title: Overall Study
STARTED	355	359
COMPLETED	237	227
NOT COMPLETED	118	132

Baseline Characteristics

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab	Total
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.	Total of all reporting groups
Overall Participants	355	359	714
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.2 (14.1)	61.2 (14.0)	61.2 (14.0)
Sex: Female, Male (Count of Participants)
Female	145 40.8%	153 42.6%	298 41.7%
Male	210 59.2%	206 57.4%	416 58.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 7.6%	20 5.6%	47 6.6%
Not Hispanic or Latino	144 40.6%	147 40.9%	291 40.8%
Unknown or Not Reported	184 51.8%	192 53.5%	376 52.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.3%	1 0.1%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	5 1.4%	5 0.7%
White	342 96.3%	348 96.9%	690 96.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	13 3.7%	5 1.4%	18 2.5%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.
Time Frame	From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Measure Participants	355	359
Median (95% Confidence Interval) [Months]	10.12	4.63

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Relatlimab + Nivolumab, Arm B: Nivolumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0055
	Comments
	Method	Log Rank
	Comments	Log-rank test stratified by LAG-3 (≥ 1% vs < 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any[0] vs M1any[1])
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").
Time Frame	From randomization to the date of death (up to approximately 3 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Overall Response Rate (ORR)
Description	Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).
Time Frame	From randomization up to approximately 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	The Number of Participants Experiencing Adverse Events (AEs)
Description	The number of participants experiencing adverse events (AEs). 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.
Time Frame	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Measure Participants	355	359
Count of Participants [Participants]	345 97.2%	339 94.4%

5. Other Pre-specified Outcome

Title	The Number of Participants Experiencing Serious Adverse Events (SAEs)
Description	The number of participants experiencing serious adverse events (SAEs). A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Time Frame	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Measure Participants	355	359
Count of Participants [Participants]	121 34.1%	105 29.2%

6. Other Pre-specified Outcome

Title	The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Description	The number of participants experiencing adverse events (AEs) leading to discontinuation. 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.
Time Frame	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Measure Participants	355	359
Count of Participants [Participants]	69 19.4%	41 11.4%

7. Other Pre-specified Outcome

Title	The Number of Participant Deaths in the Study
Description	The number of participant deaths in the study.
Time Frame	From first dose up to approximately 33 months

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Measure Participants	355	359
Count of Participants [Participants]	108 30.4%	119 33.1%

8. Other Pre-specified Outcome

Title	The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
Description	The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.
Time Frame	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Outcome Measure Data

Analysis Population Description

All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Measure Participants	342	345
ALT OR AST > 3XULN	26 7.3%	15 4.2%
ALT OR AST> 5XULN	11 3.1%	7 1.9%
ALT OR AST> 10XULN	4 1.1%	4 1.1%
ALT OR AST > 20XULN	0 0%	2 0.6%
TOTAL BILIRUBIN > 2XULN	2 0.6%	5 1.4%
ALP > 1.5xULN	34 9.6%	30 8.4%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY	2 0.6%	2 0.6%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYS	2 0.6%	2 0.6%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	2 0.6%	1 0.3%
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	2 0.6%	1 0.3%

9. Other Pre-specified Outcome

Title	The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests
Description	The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.
Time Frame	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Outcome Measure Data

Analysis Population Description

All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter.

Arm/Group Title	Arm A: Relatlimab + Nivolumab	Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
Measure Participants	328	333
TSH > ULN	106 29.9%	106 29.5%
TSH > ULN WITH TSH <= ULN AT BASELINE	84 23.7%	82 22.8%
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	63 17.7%	48 13.4%
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	7 2%	7 1.9%
TSH > ULN WITH FT3/FT4 TEST MISSING	8 2.3%	9 2.5%
TSH < LLN	89 25.1%	84 23.4%
TSH <LLN WITH TSH >= LLN AT BASELINE	79 22.3%	78 21.7%
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	51 14.4%	40 11.1%
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	6 1.7%	3 0.8%
TSH < LLN WITH FT3/FT4 TEST MISSING	11 3.1%	7 1.9%

Adverse Events

Time Frame	From first dose to up to 100 days post last dose (up to approximately 33 months)
Adverse Event Reporting Description	There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Arm/Group Title	Arm A: Relatlimab + Nivolumab		Arm B: Nivolumab
Arm/Group Description	Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.		Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents < 40 kg, dosing is 6 mg/kg.
All Cause Mortality
	Arm A: Relatlimab + Nivolumab		Arm B: Nivolumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	108/355 (30.4%)		119/359 (33.1%)
Serious Adverse Events
	Arm A: Relatlimab + Nivolumab		Arm B: Nivolumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	155/355 (43.7%)		140/359 (39%)
Blood and lymphatic system disorders
Acquired haemophilia	0/355 (0%)		1/359 (0.3%)
Anaemia	5/355 (1.4%)		4/359 (1.1%)
Bone marrow failure	1/355 (0.3%)		0/359 (0%)
Haemolytic anaemia	1/355 (0.3%)		0/359 (0%)
Cardiac disorders
Acute myocardial infarction	4/355 (1.1%)		2/359 (0.6%)
Arrhythmia	1/355 (0.3%)		0/359 (0%)
Atrial fibrillation	1/355 (0.3%)		1/359 (0.3%)
Bradycardia	1/355 (0.3%)		0/359 (0%)
Cardiac disorder	1/355 (0.3%)		0/359 (0%)
Cardiac failure	0/355 (0%)		1/359 (0.3%)
Cardiac failure congestive	0/355 (0%)		1/359 (0.3%)
Cardiogenic shock	0/355 (0%)		1/359 (0.3%)
Coronary artery disease	0/355 (0%)		1/359 (0.3%)
Heart valve incompetence	0/355 (0%)		1/359 (0.3%)
Immune-mediated myocarditis	1/355 (0.3%)		0/359 (0%)
Myocardial infarction	1/355 (0.3%)		1/359 (0.3%)
Myocardial ischaemia	0/355 (0%)		2/359 (0.6%)
Myocarditis	4/355 (1.1%)		1/359 (0.3%)
Palpitations	1/355 (0.3%)		0/359 (0%)
Right ventricular dysfunction	0/355 (0%)		1/359 (0.3%)
Sinus tachycardia	0/355 (0%)		1/359 (0.3%)
Ventricular extrasystoles	2/355 (0.6%)		0/359 (0%)
Ear and labyrinth disorders
Vertigo	1/355 (0.3%)		0/359 (0%)
Endocrine disorders
Adrenal insufficiency	5/355 (1.4%)		0/359 (0%)
Adrenocortical insufficiency acute	1/355 (0.3%)		0/359 (0%)
Adrenocorticotropic hormone deficiency	1/355 (0.3%)		0/359 (0%)
Autoimmune thyroiditis	1/355 (0.3%)		0/359 (0%)
Hyperthyroidism	0/355 (0%)		1/359 (0.3%)
Hypophysitis	1/355 (0.3%)		1/359 (0.3%)
Hypothyroidism	1/355 (0.3%)		0/359 (0%)
Lymphocytic hypophysitis	1/355 (0.3%)		0/359 (0%)
Eye disorders
Autoimmune uveitis	0/355 (0%)		1/359 (0.3%)
Papilloedema	0/355 (0%)		1/359 (0.3%)
Ulcerative keratitis	1/355 (0.3%)		0/359 (0%)
Vision blurred	0/355 (0%)		1/359 (0.3%)
Vogt-Koyanagi-Harada disease	1/355 (0.3%)		0/359 (0%)
Gastrointestinal disorders
Abdominal distension	1/355 (0.3%)		0/359 (0%)
Abdominal pain	3/355 (0.8%)		0/359 (0%)
Abdominal pain upper	0/355 (0%)		1/359 (0.3%)
Ascites	0/355 (0%)		1/359 (0.3%)
Autoimmune colitis	1/355 (0.3%)		1/359 (0.3%)
Colitis	5/355 (1.4%)		1/359 (0.3%)
Constipation	3/355 (0.8%)		0/359 (0%)
Diarrhoea	4/355 (1.1%)		3/359 (0.8%)
Gastric volvulus	1/355 (0.3%)		0/359 (0%)
Gastritis	2/355 (0.6%)		1/359 (0.3%)
Haemoperitoneum	0/355 (0%)		1/359 (0.3%)
Inguinal hernia	0/355 (0%)		1/359 (0.3%)
Intestinal obstruction	1/355 (0.3%)		1/359 (0.3%)
Melaena	1/355 (0.3%)		0/359 (0%)
Nausea	2/355 (0.6%)		0/359 (0%)
Oesophagitis	1/355 (0.3%)		0/359 (0%)
Pancreatitis	0/355 (0%)		1/359 (0.3%)
Proctalgia	0/355 (0%)		1/359 (0.3%)
Rectal haemorrhage	1/355 (0.3%)		1/359 (0.3%)
Small intestinal obstruction	1/355 (0.3%)		0/359 (0%)
Upper gastrointestinal haemorrhage	0/355 (0%)		3/359 (0.8%)
Vomiting	3/355 (0.8%)		1/359 (0.3%)
General disorders
Asthenia	1/355 (0.3%)		1/359 (0.3%)
Chest pain	0/355 (0%)		1/359 (0.3%)
Death	3/355 (0.8%)		1/359 (0.3%)
Disease progression	0/355 (0%)		1/359 (0.3%)
Fatigue	1/355 (0.3%)		1/359 (0.3%)
General physical health deterioration	2/355 (0.6%)		6/359 (1.7%)
Inflammation	0/355 (0%)		1/359 (0.3%)
Non-cardiac chest pain	1/355 (0.3%)		0/359 (0%)
Oedema peripheral	0/355 (0%)		1/359 (0.3%)
Pain	0/355 (0%)		2/359 (0.6%)
Pyrexia	3/355 (0.8%)		5/359 (1.4%)
Sudden death	0/355 (0%)		2/359 (0.6%)
Vascular stent stenosis	1/355 (0.3%)		0/359 (0%)
Hepatobiliary disorders
Autoimmune hepatitis	1/355 (0.3%)		0/359 (0%)
Bile duct stone	1/355 (0.3%)		0/359 (0%)
Cholecystitis	0/355 (0%)		1/359 (0.3%)
Cholestasis	0/355 (0%)		1/359 (0.3%)
Hepatitis	2/355 (0.6%)		0/359 (0%)
Hepatitis toxic	0/355 (0%)		1/359 (0.3%)
Hepatotoxicity	1/355 (0.3%)		0/359 (0%)
Immune-mediated cholangitis	1/355 (0.3%)		0/359 (0%)
Immune-mediated hepatitis	1/355 (0.3%)		1/359 (0.3%)
Immune system disorders
Haemophagocytic lymphohistiocytosis	1/355 (0.3%)		0/359 (0%)
Infusion related hypersensitivity reaction	0/355 (0%)		1/359 (0.3%)
Infections and infestations
Abscess soft tissue	1/355 (0.3%)		0/359 (0%)
Arthritis infective	1/355 (0.3%)		0/359 (0%)
Asymptomatic COVID-19	0/355 (0%)		1/359 (0.3%)
Atypical pneumonia	1/355 (0.3%)		1/359 (0.3%)
Bacteraemia	1/355 (0.3%)		0/359 (0%)
Bronchitis	1/355 (0.3%)		0/359 (0%)
COVID-19	3/355 (0.8%)		3/359 (0.8%)
COVID-19 pneumonia	1/355 (0.3%)		1/359 (0.3%)
Cellulitis	1/355 (0.3%)		2/359 (0.6%)
Cytomegalovirus colitis	1/355 (0.3%)		0/359 (0%)
Device related infection	1/355 (0.3%)		1/359 (0.3%)
Diverticulitis	2/355 (0.6%)		0/359 (0%)
Encephalitis	2/355 (0.6%)		1/359 (0.3%)
Erysipelas	1/355 (0.3%)		2/359 (0.6%)
Febrile infection	1/355 (0.3%)		0/359 (0%)
Gastroenteritis	0/355 (0%)		1/359 (0.3%)
Infected seroma	0/355 (0%)		1/359 (0.3%)
Infection	2/355 (0.6%)		1/359 (0.3%)
Influenza	1/355 (0.3%)		0/359 (0%)
Lower respiratory tract infection	0/355 (0%)		1/359 (0.3%)
Orchitis	1/355 (0.3%)		0/359 (0%)
Pneumonia	5/355 (1.4%)		3/359 (0.8%)
Postoperative wound infection	1/355 (0.3%)		0/359 (0%)
Pyelonephritis	0/355 (0%)		1/359 (0.3%)
Sepsis	3/355 (0.8%)		2/359 (0.6%)
Septic shock	2/355 (0.6%)		0/359 (0%)
Streptococcal sepsis	0/355 (0%)		1/359 (0.3%)
Suspected COVID-19	1/355 (0.3%)		0/359 (0%)
Tooth abscess	0/355 (0%)		1/359 (0.3%)
Tooth infection	0/355 (0%)		1/359 (0.3%)
Upper respiratory tract infection	0/355 (0%)		1/359 (0.3%)
Urinary tract infection	3/355 (0.8%)		6/359 (1.7%)
Urosepsis	1/355 (0.3%)		1/359 (0.3%)
Injury, poisoning and procedural complications
Accidental overdose	0/355 (0%)		1/359 (0.3%)
Fall	1/355 (0.3%)		2/359 (0.6%)
Hip fracture	1/355 (0.3%)		0/359 (0%)
Humerus fracture	0/355 (0%)		1/359 (0.3%)
Infusion related reaction	0/355 (0%)		2/359 (0.6%)
Jaw fracture	0/355 (0%)		1/359 (0.3%)
Lower limb fracture	0/355 (0%)		1/359 (0.3%)
Lumbar vertebral fracture	0/355 (0%)		1/359 (0.3%)
Post procedural discomfort	0/355 (0%)		1/359 (0.3%)
Post procedural haemorrhage	0/355 (0%)		1/359 (0.3%)
Postoperative thrombosis	1/355 (0.3%)		0/359 (0%)
Spinal cord injury	1/355 (0.3%)		0/359 (0%)
Spinal fracture	1/355 (0.3%)		1/359 (0.3%)
Thoracic vertebral fracture	1/355 (0.3%)		0/359 (0%)
Investigations
Blood creatine phosphokinase MB increased	0/355 (0%)		1/359 (0.3%)
Blood creatinine increased	0/355 (0%)		1/359 (0.3%)
Lipase increased	1/355 (0.3%)		0/359 (0%)
Liver function test increased	1/355 (0.3%)		0/359 (0%)
Respiratory syncytial virus test positive	1/355 (0.3%)		0/359 (0%)
Transaminases increased	1/355 (0.3%)		0/359 (0%)
Troponin T increased	0/355 (0%)		1/359 (0.3%)
Troponin increased	3/355 (0.8%)		2/359 (0.6%)
Metabolism and nutrition disorders
Dehydration	2/355 (0.6%)		1/359 (0.3%)
Diabetic ketoacidosis	0/355 (0%)		1/359 (0.3%)
Electrolyte imbalance	1/355 (0.3%)		0/359 (0%)
Hyperglycaemia	1/355 (0.3%)		0/359 (0%)
Hypoalbuminaemia	1/355 (0.3%)		0/359 (0%)
Hypocalcaemia	2/355 (0.6%)		0/359 (0%)
Hypochloraemia	1/355 (0.3%)		0/359 (0%)
Hypoglycaemia	0/355 (0%)		1/359 (0.3%)
Hypokalaemia	2/355 (0.6%)		1/359 (0.3%)
Hyponatraemia	3/355 (0.8%)		3/359 (0.8%)
Metabolic acidosis	1/355 (0.3%)		1/359 (0.3%)
Type 1 diabetes mellitus	1/355 (0.3%)		1/359 (0.3%)
Type 2 diabetes mellitus	0/355 (0%)		2/359 (0.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/355 (0.8%)		0/359 (0%)
Arthritis	1/355 (0.3%)		1/359 (0.3%)
Autoimmune arthritis	1/355 (0.3%)		1/359 (0.3%)
Back pain	4/355 (1.1%)		2/359 (0.6%)
Bursitis	1/355 (0.3%)		0/359 (0%)
Intervertebral disc protrusion	0/355 (0%)		1/359 (0.3%)
Muscular weakness	1/355 (0.3%)		1/359 (0.3%)
Myalgia	3/355 (0.8%)		0/359 (0%)
Myositis	1/355 (0.3%)		0/359 (0%)
Osteoarthritis	1/355 (0.3%)		0/359 (0%)
Osteochondrosis	1/355 (0.3%)		0/359 (0%)
Pain in extremity	0/355 (0%)		2/359 (0.6%)
Pathological fracture	1/355 (0.3%)		0/359 (0%)
Polymyalgia rheumatica	2/355 (0.6%)		0/359 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	2/355 (0.6%)		4/359 (1.1%)
Bowen's disease	0/355 (0%)		1/359 (0.3%)
Breast cancer	1/355 (0.3%)		0/359 (0%)
Cancer pain	1/355 (0.3%)		0/359 (0%)
Clear cell sarcoma of soft tissue	0/355 (0%)		1/359 (0.3%)
Infected neoplasm	1/355 (0.3%)		1/359 (0.3%)
Malignant neoplasm progression	39/355 (11%)		47/359 (13.1%)
Metastases to adrenals	0/355 (0%)		1/359 (0.3%)
Metastases to central nervous system	4/355 (1.1%)		3/359 (0.8%)
Metastases to spine	1/355 (0.3%)		0/359 (0%)
Metastasis	0/355 (0%)		1/359 (0.3%)
Renal cell carcinoma	1/355 (0.3%)		0/359 (0%)
Squamous cell carcinoma	1/355 (0.3%)		3/359 (0.8%)
Transitional cell carcinoma	1/355 (0.3%)		0/359 (0%)
Tumour associated fever	1/355 (0.3%)		0/359 (0%)
Tumour haemorrhage	1/355 (0.3%)		1/359 (0.3%)
Tumour inflammation	1/355 (0.3%)		0/359 (0%)
Tumour pain	1/355 (0.3%)		1/359 (0.3%)
Nervous system disorders
Basilar artery thrombosis	0/355 (0%)		1/359 (0.3%)
Brain oedema	0/355 (0%)		1/359 (0.3%)
Cerebral ischaemia	1/355 (0.3%)		0/359 (0%)
Cerebrovascular accident	0/355 (0%)		1/359 (0.3%)
Dysdiadochokinesis	1/355 (0.3%)		0/359 (0%)
Epilepsy	0/355 (0%)		1/359 (0.3%)
Guillain-Barre syndrome	1/355 (0.3%)		0/359 (0%)
Haemorrhagic stroke	1/355 (0.3%)		0/359 (0%)
Headache	0/355 (0%)		1/359 (0.3%)
Hypoaesthesia	1/355 (0.3%)		0/359 (0%)
Limbic encephalitis	0/355 (0%)		1/359 (0.3%)
Optic neuritis	1/355 (0.3%)		1/359 (0.3%)
Paraesthesia	1/355 (0.3%)		0/359 (0%)
Paraplegia	1/355 (0.3%)		0/359 (0%)
Radiculopathy	1/355 (0.3%)		0/359 (0%)
Seizure	0/355 (0%)		1/359 (0.3%)
Spinal cord compression	1/355 (0.3%)		0/359 (0%)
Syncope	2/355 (0.6%)		2/359 (0.6%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/355 (0.3%)		0/359 (0%)
Psychiatric disorders
Confusional state	1/355 (0.3%)		0/359 (0%)
Suicide attempt	1/355 (0.3%)		0/359 (0%)
Renal and urinary disorders
Acute kidney injury	2/355 (0.6%)		3/359 (0.8%)
Immune-mediated nephritis	1/355 (0.3%)		0/359 (0%)
Nephrolithiasis	1/355 (0.3%)		1/359 (0.3%)
Proteinuria	1/355 (0.3%)		0/359 (0%)
Renal failure	2/355 (0.6%)		0/359 (0%)
Tubulointerstitial nephritis	1/355 (0.3%)		0/359 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/355 (0.3%)		0/359 (0%)
Chronic obstructive pulmonary disease	1/355 (0.3%)		1/359 (0.3%)
Dysphonia	0/355 (0%)		1/359 (0.3%)
Dyspnoea	3/355 (0.8%)		2/359 (0.6%)
Hypoxia	0/355 (0%)		1/359 (0.3%)
Immune-mediated pneumonitis	0/355 (0%)		1/359 (0.3%)
Increased bronchial secretion	0/355 (0%)		1/359 (0.3%)
Lung disorder	0/355 (0%)		1/359 (0.3%)
Organising pneumonia	0/355 (0%)		1/359 (0.3%)
Pleural effusion	1/355 (0.3%)		2/359 (0.6%)
Pneumonia aspiration	1/355 (0.3%)		0/359 (0%)
Pneumonitis	4/355 (1.1%)		1/359 (0.3%)
Pulmonary embolism	2/355 (0.6%)		0/359 (0%)
Pulmonary oedema	1/355 (0.3%)		0/359 (0%)
Pulmonary sarcoidosis	0/355 (0%)		1/359 (0.3%)
Respiratory failure	2/355 (0.6%)		3/359 (0.8%)
Tachypnoea	0/355 (0%)		1/359 (0.3%)
Skin and subcutaneous tissue disorders
Dermatitis	0/355 (0%)		1/359 (0.3%)
Dermatitis bullous	0/355 (0%)		1/359 (0.3%)
Lichen planus	0/355 (0%)		1/359 (0.3%)
Pemphigoid	0/355 (0%)		1/359 (0.3%)
Rash	1/355 (0.3%)		1/359 (0.3%)
Rash macular	1/355 (0.3%)		0/359 (0%)
Skin ulcer	1/355 (0.3%)		0/359 (0%)
Surgical and medical procedures
Tumour excision	1/355 (0.3%)		0/359 (0%)
Vascular disorders
Aortic aneurysm	1/355 (0.3%)		0/359 (0%)
Aortic thrombosis	1/355 (0.3%)		0/359 (0%)
Deep vein thrombosis	0/355 (0%)		1/359 (0.3%)
Embolism	2/355 (0.6%)		0/359 (0%)
Hypertensive crisis	0/355 (0%)		1/359 (0.3%)
Hypovolaemic shock	2/355 (0.6%)		0/359 (0%)
Iliac artery stenosis	1/355 (0.3%)		0/359 (0%)
Shock	1/355 (0.3%)		0/359 (0%)
Other (Not Including Serious) Adverse Events
	Arm A: Relatlimab + Nivolumab		Arm B: Nivolumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	314/355 (88.5%)		298/359 (83%)
Blood and lymphatic system disorders
Anaemia	50/355 (14.1%)		37/359 (10.3%)
Endocrine disorders
Hyperthyroidism	23/355 (6.5%)		28/359 (7.8%)
Hypothyroidism	58/355 (16.3%)		47/359 (13.1%)
Gastrointestinal disorders
Abdominal pain	31/355 (8.7%)		31/359 (8.6%)
Constipation	39/355 (11%)		25/359 (7%)
Diarrhoea	82/355 (23.1%)		62/359 (17.3%)
Dry mouth	28/355 (7.9%)		18/359 (5%)
Nausea	63/355 (17.7%)		59/359 (16.4%)
Vomiting	33/355 (9.3%)		20/359 (5.6%)
General disorders
Asthenia	48/355 (13.5%)		33/359 (9.2%)
Fatigue	104/355 (29.3%)		74/359 (20.6%)
Influenza like illness	19/355 (5.4%)		14/359 (3.9%)
Oedema peripheral	26/355 (7.3%)		21/359 (5.8%)
Pyrexia	44/355 (12.4%)		33/359 (9.2%)
Infections and infestations
Urinary tract infection	38/355 (10.7%)		29/359 (8.1%)
Injury, poisoning and procedural complications
Infusion related reaction	21/355 (5.9%)		12/359 (3.3%)
Investigations
Alanine aminotransferase increased	36/355 (10.1%)		21/359 (5.8%)
Aspartate aminotransferase increased	35/355 (9.9%)		17/359 (4.7%)
Blood creatinine increased	21/355 (5.9%)		12/359 (3.3%)
Troponin increased	27/355 (7.6%)		18/359 (5%)
Weight decreased	27/355 (7.6%)		15/359 (4.2%)
Metabolism and nutrition disorders
Decreased appetite	55/355 (15.5%)		27/359 (7.5%)
Hyperglycaemia	19/355 (5.4%)		24/359 (6.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	84/355 (23.7%)		54/359 (15%)
Back pain	48/355 (13.5%)		30/359 (8.4%)
Myalgia	34/355 (9.6%)		19/359 (5.3%)
Pain in extremity	28/355 (7.9%)		16/359 (4.5%)
Nervous system disorders
Dizziness	21/355 (5.9%)		24/359 (6.7%)
Headache	64/355 (18%)		47/359 (13.1%)
Paraesthesia	18/355 (5.1%)		5/359 (1.4%)
Respiratory, thoracic and mediastinal disorders
Cough	50/355 (14.1%)		38/359 (10.6%)
Dyspnoea	33/355 (9.3%)		22/359 (6.1%)
Skin and subcutaneous tissue disorders
Pruritus	88/355 (24.8%)		62/359 (17.3%)
Rash	62/355 (17.5%)		49/359 (13.6%)
Vitiligo	39/355 (11%)		37/359 (10.3%)
Vascular disorders
Hypertension	21/355 (5.9%)		14/359 (3.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.