A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: rHuPH20; Drug: Nivolumab + Relatlimab

• Study Type: Interventional
• Enrollment (Actual): 579
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Local Institution - 0050
    • Orange, New South Wales, Australia, 2800
      • Local Institution - 0175
    • Port Macquarie, New South Wales, Australia, 2444
      • Local Institution - 0172
    • Wagga Wagga, New South Wales, Australia, 2650
      • Local Institution - 0118
    • Waratah, New South Wales, Australia, 2298
      • Local Institution - 0184
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 0033
    • Wollstonecraft, New South Wales, Australia, 2065
      • Local Institution - 0055
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Local Institution - 0090
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Local Institution - 0008
    • Box Hill, Victoria, Australia, 3128
      • Local Institution - 0059
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution - 0154
    • Melbourne, Victoria, Australia, 3004
      • Local Institution - 0030
    • Traralgon, Victoria, Australia, 3844
      • Local Institution - 0109
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Local Institution - 0106
    • Nedlands, Western Australia, Australia, 6009
      • Local Institution - 0161
• Austria
  • Graz, Austria, 8036
    • Local Institution - 0027
  • Salzburg, Austria, 5020
    • Local Institution - 0029
  • Sankt Pölten, Austria, 3100
    • Local Institution - 0168
  • Vienna, Austria, 1090
    • Local Institution - 0037
• Belgium
  • Brussels, Belgium, 1200
    • Local Institution - 0072
  • Charleroi, Belgium, 6000
    • Local Institution - 0078
  • Liège, Belgium, 4000
    • Local Institution - 0016
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60135237
      • Local Institution - 0177
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29043-260
      • Local Institution - 0180
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-090
      • Local Institution - 0107
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • Local Institution - 0025
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Local Institution - 0031
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Local Institution - 0058
    • Porto Alegrelegre, Rio Grande do Sul, Brazil, 91350-250
      • Local Institution - 0002
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 20220-410
      • Local Institution - 0110
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-340
      • Local Institution - 0159
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Local Institution - 0009
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Local Institution - 0018
    • São Paulo, São Paulo, Brazil, 01321-001
      • Local Institution - 0130
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Local Institution - 0141
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Local Institution - 0121
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution - 0096
    • Toronto, Ontario, Canada, M4N 3M5
      • Local Institution - 0116
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • Local Institution - 0103
• Chile
  • Santiago, Chile, 7500921
    • Local Institution - 0017
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • Local Institution - 0143
  • Los Lagos Region
    • Port Montt, Los Lagos Region, Chile, 5507642
      • Local Institution - 0178
  • Providencia
    • Santiago, Providencia, Chile, 7500653
      • Local Institution - 0119
  • Santiago Metropolitan
    • Recoleta, Santiago Metropolitan, Chile, 8380455
      • Local Institution - 0140
    • Santiago, Santiago Metropolitan, Chile, 0101010
      • Local Institution - 0144
    • Santiago, Santiago Metropolitan, Chile, 7510032
      • Local Institution - 0010
    • Santiago, Santiago Metropolitan, Chile, 8150513
      • Local Institution - 0074
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • Local Institution - 0028
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Local Institution - 0094
  • Olomouc, Czechia, 77900
    • Local Institution - 0091
  • Ostrava Poruba, Czechia, 708 52
    • Local Institution - 0082
  • Prague, Czechia, 182 00
    • Local Institution - 0095
  • NY
    • Prague, NY, Czechia, 128 00
      • Local Institution - 0083
• Finland
  • Helsinki, Finland, 00029
    • Local Institution - 0164
  • Tampere, Finland, 33521
    • Local Institution - 0167
  • Turku, Finland, 20520
    • Local Institution - 0162
• France
  • Amiens, France, 80054
    • Local Institution - 0007
  • Bayonne, France, 64100
    • Local Institution - 0128
  • Bordeaux, France, 33000
    • Local Institution - 0022
  • Clermont-Ferrand, France, 63003
    • Local Institution - 0129
  • Dijon, France, 21079
    • Local Institution - 0046
  • Marseille, France, 13385
    • Local Institution - 0117
  • Pierre-Bénite, France, 69310
    • Local Institution - 0052
  • Rennes, France, 35042
    • Local Institution - 0089
  • Rouen, France, 76031
    • Local Institution - 0099
  • Cedex 9
    • Toulouse, Cedex 9, France, 31059
      • Local Institution - 0108
  • Indre-Et-Loire
    • Chambray-lès-Tours, Indre-Et-Loire, France, 37044
      • Local Institution - 0127
  • Nord
    • Lille, Nord, France, 59000
      • Local Institution - 0111
  • OH
    • Nantes, OH, France, 44093
      • Local Institution - 0063
  • Val-De-Marne
    • Villejuif, Val-De-Marne, France, 94805
      • Local Institution - 0061
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75475
      • Local Institution - 0034
• Germany
  • Berlin, Germany, 10117
    • Local Institution - 0060
  • Buxtehude, Germany, 21614
    • Local Institution - 0038
  • Dortmund, Germany, 44137
    • Local Institution - 0136
  • Erfurt, Germany, 99089
    • Local Institution - 0039
  • Essen, Germany, 45147
    • Local Institution - 0049
  • Frankfurt am Main, Germany, 60590
    • Local Institution - 0166
  • Giessen, Germany, 35385
    • Local Institution - 0065
  • Göttingen, Germany, 37075
    • Local Institution - 0135
  • Hamburg, Germany, 20251
    • Local Institution - 0138
  • Ludwigshafen, Germany, 67063
    • Local Institution - 0137
  • Marburg, Germany, 35043
    • Local Institution - 0165
  • Minden, Germany, 32429
    • Local Institution - 0044
  • Nuremberg, Germany, 90419
    • Local Institution - 0112
  • Rostock, Germany, 18057
    • Local Institution - 0053
  • Tübingen, Germany, 72076
    • Local Institution - 0081
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Local Institution - 0101
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Local Institution - 0079
  • Bavaria
    • Regensburg, Bavaria, Germany, 93042
      • Local Institution - 0011
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Local Institution - 0003
• Israel
  • Afula, Israel, 1834111
    • Local Institution - 0026
  • Petah-Tikvah, Israel, 4941492
    • Local Institution - 0102
  • Tel Aviv, Israel, 6423906
    • Local Institution - 0173
  • Tel Litwinsky, Israel, 5262100
    • Local Institution - 0035
  • Israel
    • Jerusalem, Israel, Israel, 9112001
      • Local Institution - 0054
• Italy
  • Bari, Italy, 70124
    • Local Institution - 0051
  • Milan, Italy, 20133
    • Local Institution - 0170
  • Naples, Italy, 80131
    • Local Institution - 0084
  • Perugia, Italy, 06132
    • Local Institution - 0032
  • Roma, Italy, 00168
    • Local Institution - 0064
  • Genova
    • Genova, Genova, Italy, 16132
      • Local Institution - 0077
  • Siena
    • Siena, Siena, Italy, 53100
      • Local Institution - 0014
• Norway
  • Bodø, Norway, 8005
    • Local Institution - 0163
  • Grålum, Norway, 1714
    • Local Institution - 0156
  • Lørenskog, Norway, 1474
    • Local Institution - 0158
  • Oslo, Norway, 0379
    • Local Institution - 0155
• Poland
  • Warsaw, Poland, 02-781
    • Local Institution - 0066
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Local Institution - 0171
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30727
      • Local Institution - 0021
  • Opole Voivodeship
    • Opole, Opole Voivodeship, Poland, 45-061
      • Local Institution - 0005
  • Wiekopolskie
    • Poznan, Wiekopolskie, Poland, 60-780
      • Local Institution - 0015
• Spain
  • Badalona, Spain, 08916
    • Local Institution - 0134
  • Barcelona, Spain, 08036
    • Local Institution - 0024
  • Las Palmas de Gran Canaria, Spain, 35016
    • Local Institution - 0045
  • Madrid, Spain, 28007
    • Local Institution - 0040
  • Madrid, Spain, 28050
    • Local Institution - 0056
  • Seville, Spain, 41009
    • Local Institution - 0006
  • Valencia, Spain, 46014
    • Local Institution - 0151
  • Valencia, Spain, 46009
    • Local Institution - 0043
  • A Coruna
    • A Coruña, A Coruna, Spain, 15006
      • Local Institution - 0086
  • Barcelona
    • Barcelona, Barcelona, Spain, 08035
      • Local Institution - 0047
  • Gipuzkoa
    • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
      • Local Institution - 0012
  • Jaen
    • Jaén, Jaen, Spain, 23007
      • Local Institution - 0153
  • Madrid
    • Madrid, Madrid, Spain, 28009
      • Local Institution - 0126
    • Madrid, Madrid, Spain, 28041
      • Local Institution - 0004
  • Valencia
    • Valencia, Valencia, Spain, 46009
      • Local Institution - 0041
• Sweden
  • Lund, Sweden, 222 42
    • Local Institution - 0097
  • Stockholm County
    • Solna, Stockholm County, Sweden, 171 64
      • Local Institution - 0062
• Switzerland
  • Bern, Switzerland, 3010
    • Local Institution - 0092
  • Chur, Switzerland, 7000
    • Local Institution - 0080
  • Lausanne, Switzerland, 1011
    • Local Institution - 0105
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SW3 6JJ
      • Local Institution - 0088
  • Oxfordshire
    • Headington, Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Local Institution - 0068
  • Tyne and Wear
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
      • Local Institution - 0120
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Local Institution - 0125
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Local Institution - 0189
  • California
    • Los Angeles, California, United States, 90025
      • Local Institution - 0098
    • Orange, California, United States, 92868-3201
      • Local Institution - 0093
    • Stanford, California, United States, 94305
      • Local Institution - 0123
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Local Institution - 0113
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Local Institution - 0114
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Local Institution - 0146
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 0071
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Local Institution - 0013
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Local Institution - 0169
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Local Institution - 0139
    • Philadelphia, Pennsylvania, United States, 19107
      • Local Institution - 0124
  • Utah
    • Murray, Utah, United States, 84107
      • Local Institution - 0122
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Local Institution - 0115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
• Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
• Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
• Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria

• Participants must not have ocular melanoma.
• Participants must not have a history of myocarditis, regardless of etiology.
• Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nivolumab + Relatlimab FDC SC	Drug: rHuPH20; Specified dose on specified days; Drug: Nivolumab + Relatlimab; Specified dose on specified days; Other Names: BMS-986213; Opdualag
Active Comparator: Nivolumab + Relatlimab FDC IV	Drug: Nivolumab + Relatlimab; Specified dose on specified days; Other Names: BMS-986213; Opdualag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale	Blood samples were collected to assess serum concentration.	Pre-dose (Day 1 to Day 28)
Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale	Blood samples were collected to assess serum concentration.	Pre-dose (Day 1 to Day 28)
Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale	Blood samples were collected to assess serum concentration.	Pre-dose (Day 1 to Day 28)
Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale	Blood samples were collected to assess serum concentration.	Pre-dose (Day 1 to Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) by BICR	Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per BICR	Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per BICR	Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria. 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: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per BICR	Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per BICR	Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Objective Response Rate (ORR) Per Investigator	Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on Investigator assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per Investigator	Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on Investigator assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per Investigator	Time to response (TTR) assessed by Investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria. 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: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per Investigator	Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per Investigator	Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Overall Survival (OS)	Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause. Median computed using Kaplan-Meier method.	From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Trough Serum Concentration of Nivolumab and Relatlimab (Cmind28) at Day 28	Blood samples were collected to assess serum concentration.	Pre-dose at Day 28
Peak Serum Concentration (Cmax1) After the First Dose of Nivolumab and Relatlimab	Blood samples were collected to assess serum concentration.	Post-dose Day 1
Maximum Observed Concentration at Steady State (Cmaxss) Nivolumab and Relatlimab	Blood samples were collected to assess serum concentration.	Post-dose Day 1
Average Observed Concentration at Steady State (Cavgss) of Nivolumab and Relatlimab	Blood samples were collected to assess serum concentration.	Post-dose Day 1
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths	AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.	First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Number of Participants With Immune-mediate Adverse Events (IMAEs)	AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.	First dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months)
Number of Participants With Other Event of Special Interest (OESI)	AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.	First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 28 months)
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters	AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.	First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Change From Baseline Functional Assessment of Cancer Therapy -Melanoma (FACT-M) Total Score	The FACT-M questionnaire was used to assess the effects of disease symptoms on functioning and well-being. As a generic cancer-related core, the FACT-M includes the 27-item FACT General (FACT-G) to assess physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). In addition, the FACT-M includes a 16-item disease-specific Melanoma Subscale (MS). Each FACT-M item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much). Scores for the PWB, FWB, SWB, and EWB subscales can be combined to produce a FACT-G total score, which provides an overall indicant of generic quality of life, while the FACT-G and MS scores can be combined to produce a total score for the FACT-M, which provides a composite measure of general and targeted quality of life. Overall scale ranges from 0 to 172, higher values indicate better functioning as well as lower symptom burden.	Baseline (Day 1) and Week 85

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Halozyme Therapeutics
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): August 4, 2025
• Study Completion (Estimated): November 18, 2027

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Nivolumab; Melanoma; Relatlimab; rHuPH20; FDC; OPDUALAG
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; relatlimab; Opdualag
• Other Study ID Numbers: CA224-127; U1111-1274-0193 (Other Identifier: WHO); 2022-500967-11-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No