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

NCT05625399 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CA224-1272022-000575-39U1111-1274-0193
• Study Type: interventional
• Target: 579
• Locations: 18 countries
• Sites: 145

Brief Summary

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.

Conditions

Melanoma

Keywords

Nivolumab; Relatlimab; FDC; Melanoma; rHuPH20; OPDUALAG

Outcome Measures

Primary Outcomes (4)

• Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab

  Up to 28 days

• Trough serum concentration at steady state (Cminss) of Nivolumab

  Up to 4 months

• Cavgd28 of Relatlimab

  Up to 28 days

• Cminss of Relatlimab

  Up to 4 months

Secondary Outcomes (17)

• Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1

  Up to approximately 3 years

• Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab

  Up to 28 days

• Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab

  Up to 28 days

• Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab

  Up to 28 days

• Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab

  Up to 4 months

Study Arms (2)

Nivolumab + Relatlimab FDC SC

EXPERIMENTAL

Drug: Nivolumab + Relatlimab; Drug: rHuPH20

Nivolumab + Relatlimab FDC IV

ACTIVE COMPARATOR

Drug: Nivolumab + Relatlimab

Interventions

Nivolumab + Relatlimab DRUG

Specified dose on specified days

Also known as: BMS-986213, Opdualag

Nivolumab + Relatlimab FDC IV; Nivolumab + Relatlimab FDC SC

rHuPH20 DRUG

Specified dose on specified days

Nivolumab + Relatlimab FDC SC

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (149)

Local Institution - 0125

Phoenix, Arizona, 85013, United States

Location

Local Institution - 0189

Springdale, Arkansas, 72762, United States

Location

Local Institution - 0098

Los Angeles, California, 90025, United States

Location

Local Institution - 0093

Orange, California, 92868-3201, United States

Location

Local Institution - 0123

Stanford, California, 94305, United States

Location

Local Institution - 0113

Englewood, Colorado, 80113, United States

Location

Local Institution - 0114

Jacksonville, Florida, 32224, United States

Location

Local Institution - 0146

Baltimore, Maryland, 21201, United States

Location

Local Institution - 0071

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0013

Omaha, Nebraska, 68130, United States

Location

Local Institution - 0169

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0139

Easton, Pennsylvania, 18045, United States

Location

Local Institution - 0124

Philadelphia, Pennsylvania, 19107, United States

Location

Local Institution - 0122

Murray, Utah, 84107, United States

Location

Local Institution - 0115

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0050

Coffs Harbour, New South Wales, 2450, Australia

Location

Local Institution - 0175

Orange, New South Wales, 2800, Australia

Location

Local Institution - 0172

Port Macquarie, New South Wales, 2444, Australia

Location

Local Institution - 0118

Wagga Wagga, New South Wales, 2650, Australia

Location

Local Institution - 0184

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0033

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0055

Wollstonecraft, New South Wales, 2065, Australia

Location

Local Institution - 0090

Birtinya, Queensland, 4575, Australia

Location

Local Institution - 0008

Bendigo, Victoria, 3550, Australia

Location

Local Institution - 0059

Box Hill, Victoria, 3128, Australia

Location

Local Institution - 0154

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0030

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 0109

Traralgon, Victoria, 3844, Australia

Location

Local Institution - 0106

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0161

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0027

Graz, 8036, Austria

Location

Local Institution - 0029

Salzburg, 5020, Austria

Location

Local Institution - 0168

Sankt Pölten, 3100, Austria

Location

Local Institution - 0037

Vienna, 1090, Austria

Location

Local Institution - 0072

Brussels, 1200, Belgium

Location

Local Institution - 0078

Charleroi, 6000, Belgium

Location

Local Institution - 0016

Liège, 4000, Belgium

Location

Local Institution - 0177

Fortaleza, Ceará, 60135237, Brazil

Location

Local Institution - 0180

Vitória, Espírito Santo, 29043-260, Brazil

Location

Local Institution - 0107

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0025

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0031

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Local Institution - 0058

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0002

Porto Alegrelegre, Rio Grande do Sul, 91350-250, Brazil

Location

Local Institution - 0159

Blumenau, Santa Catarina, 89010-340, Brazil

Location

Local Institution - 0009

Barretos, São Paulo, 14784-400, Brazil

Location

Local Institution - 0018

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Local Institution - 0110

Rio de Janeiro, 20220-410, Brazil

Location

Local Institution - 0130

São Paulo, 01321-001, Brazil

Location

Local Institution - 0141

Calgary, Alberta, T2N 5G2, Canada

Location

Local Institution - 0121

Hamilton, Ontario, L8V 5C2, Canada

Location

Local Institution - 0096

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0116

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution - 0103

Québec, Quebec, G1J 1Z4, Canada

Location

Local Institution - 0178

Port Montt, Los Lagos Region, 5507642, Chile

Location

Local Institution - 0119

Santiago, Providencia, 7500653, Chile

Location

Local Institution - 0143

Temuco, Región de la Araucanía, 4800827, Chile

Location

Local Institution - 0028

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0140

Recoleta, Santiago Metropolitan, 8380455, Chile

Location

Local Institution - 0144

Santiago, Santiago Metropolitan, 0101010, Chile

Location

Local Institution - 0010

Santiago, Santiago Metropolitan, 7510032, Chile

Location

Local Institution - 0074

Santiago, Santiago Metropolitan, 8150513, Chile

Location

Local Institution - 0017

Santiago, 7500921, Chile

Location

Local Institution - 0083

Prague, NY, 128 00, Czechia

Location

Local Institution - 0094

Hradec Králové, 500 05, Czechia

Location

Local Institution - 0091

Olomouc, 77900, Czechia

Location

Local Institution - 0082

Ostrava Poruba, 708 52, Czechia

Location

Local Institution - 0095

Prague, 182 00, Czechia

Location

Local Institution - 0164

Helsinki, 00029, Finland

Location

Local Institution - 0167

Tampere, 33521, Finland

Location

Local Institution - 0162

Turku, 20520, Finland

Location

Local Institution - 0108

Toulouse, Cedex 9, 31059, France

Location

Local Institution - 0127

Chambray-lès-Tours, Indre-Et-Loire, 37044, France

Location

Local Institution - 0111

Lille, Nord, 59000, France

Location

Local Institution - 0063

Nantes, OH, 44093, France

Location

Local Institution - 0061

Villejuif, Val-De-Marne, 94805, France

Location

Local Institution - 0007

Amiens, 80054, France

Location

Local Institution - 0128

Bayonne, 64100, France

Location

Local Institution - 0022

Bordeaux, 33000, France

Location

Local Institution - 0129

Clermont-Ferrand, 63003, France

Location

Local Institution - 0046

Dijon, 21079, France

Location

Local Institution - 0117

Marseille, 13385, France

Location

Local Institution - 0052

Pierre-Bénite, 69310, France

Location

Local Institution - 0089

Rennes, 35042, France

Location

Local Institution - 0099

Rouen, 76031, France

Location

Local Institution - 0034

Paris, Île-de-France Region, 75475, France

Location

Local Institution - 0101

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Local Institution - 0079

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Institution - 0011

Regensburg, Bavaria, 93042, Germany

Location

Local Institution - 0003

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Local Institution - 0060

Berlin, 10117, Germany

Location

Local Institution - 0038

Buxtehude, 21614, Germany

Location

Local Institution - 0136

Dortmund, 44137, Germany

Location

Local Institution - 0039

Erfurt, 99089, Germany

Location

Local Institution - 0049

Essen, 45147, Germany

Location

Local Institution - 0166

Frankfurt am Main, 60590, Germany

Location

Local Institution - 0065

Giessen, 35385, Germany

Location

Local Institution - 0135

Göttingen, 37075, Germany

Location

Local Institution - 0138

Hamburg, 20251, Germany

Location

Local Institution - 0137

Ludwigshafen, 67063, Germany

Location

Local Institution - 0165

Marburg, 35043, Germany

Location

Local Institution - 0044

Minden, 32429, Germany

Location

Local Institution - 0112

Nuremberg, 90419, Germany

Location

Local Institution - 0053

Rostock, 18057, Germany

Location

Local Institution - 0081

Tübingen, 72076, Germany

Location

Local Institution - 0026

Afula, 1834111, Israel

Location

Local Institution - 0054

Jerusalem, 9112001, Israel

Location

Local Institution - 0102

Petah-Tikvah, 4941492, Israel

Location

Local Institution - 0173

Tel Aviv, 6423906, Israel

Location

Local Institution - 0035

Tel Litwinsky, 5262100, Israel

Location

Local Institution - 0051

Bari, 70124, Italy

Location

Local Institution - 0077

Genova, 16132, Italy

Location

Local Institution - 0170

Milan, 20133, Italy

Location

Local Institution - 0084

Napoli, 80131, Italy

Location

Local Institution - 0032

Perugia, 06132, Italy

Location

Local Institution - 0064

Roma, 00168, Italy

Location

Local Institution - 0014

Siena, 53100, Italy

Location

Local Institution - 0163

Bodø, 8005, Norway

Location

Local Institution - 0156

Grålum, 1714, Norway

Location

Local Institution - 0158

Lørenskog, 1474, Norway

Location

Local Institution - 0155

Oslo, 0379, Norway

Location

Local Institution - 0171

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Local Institution - 0021

Krakow, Lesser Poland Voivodeship, 30727, Poland

Location

Local Institution - 0005

Opole, Opole Voivodeship, 45-061, Poland

Location

Local Institution - 0015

Poznan, Wiekopolskie, 60-780, Poland

Location

Local Institution - 0066

Warsaw, 02-781, Poland

Location

Local Institution - 0012

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Local Institution - 0086

A Coruña, 15006, Spain

Location

Local Institution - 0134

Badalona, 08916, Spain

Location

Local Institution - 0047

Barcelona, 08035, Spain

Location

Local Institution - 0024

Barcelona, 08036, Spain

Location

Local Institution - 0153

Jaén, 23007, Spain

Location

Local Institution - 0045

Las Palmas de Gran Canaria, 35016, Spain

Location

Local Institution - 0040

Madrid, 28007, Spain

Location

Local Institution - 0126

Madrid, 28009, Spain

Location

Local Institution - 0004

Madrid, 28041, Spain

Location

Local Institution - 0056

Madrid, 28050, Spain

Location

Local Institution - 0006

Seville, 41009, Spain

Location

Local Institution - 0041

Valencia, 46009, Spain

Location

Local Institution - 0043

Valencia, 46009, Spain

Location

Local Institution - 0151

Valencia, 46014, Spain

Location

Local Institution - 0062

Solna, Stockholm County, 171 64, Sweden

Location

Local Institution - 0097

Lund, 222 42, Sweden

Location

Local Institution - 0092

Bern, 3010, Switzerland

Location

Local Institution - 0080

Chur, 7000, Switzerland

Location

Local Institution - 0105

Lausanne, 1011, Switzerland

Location

Local Institution - 0088

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0068

Headington, Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Local Institution - 0120

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; relatlimab; Opdualag

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 22, 2022
• Study Start: March 6, 2023
• Primary Completion: August 4, 2025
• Study Completion (Estimated): November 18, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

GB (3); IT (7); CA (5); US (15); CZ (5); PL (5); AU (15); DE (19); CL (9); FR (15); BE (3); BR (12); IL (5); NO (4); SE (2); ES (15); CH (3); FI (3)