A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

NCT05002569 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA224-0982021-001641-13
• Study Type: interventional
• Target: 1,093
• Locations: 24 countries
• Sites: 181

Brief Summary

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Conditions

Melanoma

Keywords

Melanoma; Relatlimab; Nivolumab; Opdivo

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival (RFS)

  RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.

  Approximately 27.5 Months

Secondary Outcomes (8)

• Overall Survival (OS)

  Approximately 27.5 Months

• Distant Metastasis Free Survival (DMFS)

  Approximately 27.5 Months

• Progression Free Survival on Next-Line Systemic Therapy (PFS2)

  Approximately 27.5 Months

• Number of Participants With Safety Related Events

  Approximately 27.5 Months

• Number of Participants With Select AEs

  Approximately 27.5 Months

Study Arms (2)

Arm A: Nivolumab Plus Relatlimab

EXPERIMENTAL

Combination

Biological: Nivolumab + Relatlimab Fixed Dose Combination

Arm B: Nivolumab

EXPERIMENTAL

Monotherapy

Biological: Nivolumab

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm B: Nivolumab

Nivolumab + Relatlimab Fixed Dose Combination BIOLOGICAL

Specified dose on specified days

Also known as: BMS-986213, Opdualag

Arm A: Nivolumab Plus Relatlimab

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:

• Must have been diagnosed with either Stage IIIA (\> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
• Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and \< 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
• Complete resection must be performed within 90 days prior to randomization
• All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
• Tumor tissue must be provided for biomarker analyses

You may not qualify if:

• History of ocular melanoma
• Untreated/unresected CNS metastases or leptomeningeal metastases
• Active, known, or suspected autoimmune disease
• Participants with serious or uncontrolled medical disorder
• Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
• History of myocarditis, regardless of etiology.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (184)

Local Institution - 0176

Birmingham, Alabama, 35249, United States

Location

Local Institution - 0164

Springdale, Arkansas, 72762, United States

Location

Local Institution - 0200

Los Angeles, California, 90025, United States

Location

Local Institution - 0185

Palo Alto, California, 94304, United States

Location

Local Institution - 0162

San Francisco, California, 94115, United States

Location

Saint John's Cancer Institute

Santa Monica, California, 90404, United States

Location

Local Institution - 0138

Aurora, Colorado, 80045, United States

Location

Local Institution - 0166

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0243

Miami, Florida, 33136, United States

Location

Washington University School Of Medicine

Miami, Florida, 33136, United States

Location

Local Institution - 0179

Pensacola, Florida, 32504, United States

Location

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, 33612, United States

Location

Local Institution - 0191

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0148

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0202

Chicago, Illinois, 60611, United States

Location

Local Institution - 0177

Peoria, Illinois, 61615, United States

Location

Local Institution - 0223

Fort Wayne, Indiana, 46804, United States

Location

University of Iowa-Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Local Institution - 0178

Westwood, Kansas, 66205, United States

Location

Dana-Farber Cancer Institute-Melanoma

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0258

Ann Arbor, Michigan, 48109, United States

Location

Local Institution

Grand Rapids, Michigan, 49503, United States

Location

Local Institution - 0133

Minneapolis, Minnesota, 55407, United States

Location

Local Institution - 0139

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0206

Morristown, New Jersey, 07960, United States

Location

Local Institution - 0140

New York, New York, 10016, United States

Location

Icahn School Of Medicine At Mount Sinai

New York, New York, 10029, United States

Location

Local Institution - 0210

New York, New York, 10065, United States

Location

Local Institution - 0130

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0145

Durham, North Carolina, 27710, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Local Institution - 0141

Cleveland, Ohio, 44195, United States

Location

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

Columbus, Ohio, 43210, United States

Location

Local Institution - 0267

Allentown, Pennsylvania, 18103, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution - 0125

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0171

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0147

Germantown, Tennessee, 38138, United States

Location

Local Institution - 0183

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0146

Austin, Texas, 78731, United States

Location

Local Institution - 0163

Dallas, Texas, 75246, United States

Location

Local Institution - 0172

Houston, Texas, 77030, United States

Location

Local Institution - 0137

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0003

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

Location

Local Institution - 0005

Buenos Aires, Distrito Federal, 1426, Argentina

Location

Local Institution - 0001

CABA, Distrito Federal, C1430, Argentina

Location

Local Institution - 0002

Ciudad de Buenos Aires, Distrito Federal, C1121ABE, Argentina

Location

Local Institution - 0004

Córdoba, X5002HWE, Argentina

Location

Local Institution - 0030

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0252

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0032

Wollstonecraft, New South Wales, 2065, Australia

Location

Local Institution - 0254

Tiwi, Northern Territory, 0810, Australia

Location

Local Institution - 0028

Brisbane, Queensland, 4102, Australia

Location

Local Institution - 0027

Southport, Queensland, 4215, Australia

Location

Local Institution - 0250

Woodville, South Australia, 5011, Australia

Location

Local Institution - 0035

Ballarat, Victoria, 3350, Australia

Location

Local Institution - 0253

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0031

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 0251

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0029

Perth, Western Australia, 6009, Australia

Location

Local Institution - 0082

Graz, Styria, 8036, Austria

Location

Local Institution - 0086

Salzburg, 5020, Austria

Location

Local Institution - 0084

Vienna, 1090, Austria

Location

Local Institution - 0110

Brussels, 1090, Belgium

Location

Local Institution - 0105

Brussels, 1200, Belgium

Location

Local Institution - 0109

Liège, 4000, Belgium

Location

Local Institution - 0106

Wilrijk, 2610, Belgium

Location

Local Institution - 0072

Fortaleza, Ceará, 60135237, Brazil

Location

Local Institution - 0068

Vitória, Espírito Santo, 29055450, Brazil

Location

Local Institution - 0071

Salvador, Estado de Bahia, 40170-070, Brazil

Location

Local Institution - 0047

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0056

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

Location

Local Institution - 0257

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

Location

Local Institution - 0049

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution - 0048

Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil

Location

Local Institution - 0070

Barretos, São Paulo, 14784400, Brazil

Location

Local Institution - 0058

Rio de Janeiro, 20220-410, Brazil

Location

Local Institution - 0155

Edmonton, Alberta, T6X 1E8, Canada

Location

Local Institution - 0175

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0197

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution - 0159

Montreal, Quebec, H2X 1P1, Canada

Location

Local Institution - 0158

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0160

Québec, Quebec, G1J 1Z4, Canada

Location

Local Institution - 0198

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Local Institution - 0013

Santiago, Santiago Metropolitan, 7510032, Chile

Location

Local Institution - 0006

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0014

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0221

Hefei, Anhui, 230022, China

Location

Local Institution - 0259

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0261

Beijing, Beijing Municipality, 100035, China

Location

Local Institution - 0214

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0241

Chongqing, Chongqing Municipality, 400030, China

Location

Local Institution - 0245

Fuzhou, Fujian, 350014, China

Location

Local Institution - 0217

Guangzhou, Guangdong, 510060, China

Location

Local Institution - 0226

Zhengzhou, Henan, 450001, China

Location

Local Institution - 0237

Wuhan, Hubei, 430022, China

Location

Local Institution - 0239

Wuhan, Hubei, 430030, China

Location

Local Institution - 0234

Changsha Shi, Hunan, 410013, China

Location

Local Institution - 0215

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0225

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0224

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0219

Changchun, Jilin, 130021, China

Location

Local Institution - 0242

Shenyang, Liaoning, 110001, China

Location

Local Institution - 0230

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0263

Tianjin, Tianjin Municipality, 300060, China

Location

Local Institution - 0228

Ürümqi, Xinjiang, 830000, China

Location

Local Institution - 0222

Kunming, Yunnan, 650106, China

Location

Local Institution - 0220

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0216

Hangzhou, Zhejiang, 310022, China

Location

Local Institution - 0244

Taiyuan, 030032, China

Location

Local Institution - 0156

Brno, 65653, Czechia

Location

Local Institution - 0091

Hradec Králové, 50005, Czechia

Location

Local Institution - 0026

Ostrava, 708 52, Czechia

Location

Local Institution - 0062

Prague, 12808, Czechia

Location

Local Institution - 0016

Aarhus, Central Jutland, 8200, Denmark

Location

Local Institution - 0022

Aalborg, 9100, Denmark

Location

Local Institution - 0018

Copenhagen, 2730, Denmark

Location

Local Institution - 0020

Odense, 5000, Denmark

Location

Helsinki University Hospital Adult ICU PPDS

Helsinki, 00290, Finland

Location

Local Institution - 0019

Tampere, 33520, Finland

Location

Local Institution - 0015

Turku, 20521, Finland

Location

Local Institution - 0040

Villejuif, Val-de-Marne, 94800, France

Location

Local Institution - 0043

Dijon, 21000, France

Location

Local Institution - 0044

Marseille, 13385, France

Location

Local Institution - 0039

Nantes, 44093, France

Location

Local Institution - 0042

Paris, 75010, France

Location

Local Institution - 0041

Pierre-Bénite, 69310, France

Location

Local Institution - 0046

Toulouse, 31100, France

Location

Local Institution - 0092

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Local Institution - 0079

Hanover, Lower Saxony, 30625, Germany

Location

Local Institution - 0073

Buxtehude, 21614, Germany

Location

Local Institution - 0077

Dresden, 01307, Germany

Location

Local Institution - 0074

Erlangen, 91054, Germany

Location

Local Institution - 0131

Essen, 45147, Germany

Location

Local Institution - 0081

Gera, 07548, Germany

Location

Local Institution - 0075

Heidelberg, D-69120, Germany

Location

Local Institution - 0078

Lübeck, 23538, Germany

Location

Local Institution - 0083

Minden, 32429, Germany

Location

Local Institution - 0076

Munich, 80337, Germany

Location

Local Institution - 0080

Würzburg, 97080, Germany

Location

Local Institution - 0114

Athens, 11527, Greece

Location

Local Institution - 0113

Neo Faliro, 185 47, Greece

Location

Local Institution - 0112

Thessaloniki, 540 07, Greece

Location

Local Institution - 0199

Petah Tikva, Central District, 4941492, Israel

Location

Local Institution - 0118

Jerusalem, Jerusalem, 9112001, Israel

Location

Local Institution - 0116

Afula, 1834111, Israel

Location

Local Institution - 0117

Ramat Gan, 5262100, Israel

Location

Local Institution - 0115

Milan, 20133, Italy

Location

Local Institution - 0268

Milan, 20133, Italy

Location

Local Institution - 0123

Milan, 20141, Italy

Location

Local Institution - 0119

Naples, 80131, Italy

Location

Local Institution - 0120

Padua, 35128, Italy

Location

Local Institution - 0122

Perugia, 06132, Italy

Location

Local Institution - 0121

Siena, 53100, Italy

Location

Local Institution - 0021

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0100

Benito Juárez, Mexico City, 03240, Mexico

Location

Local Institution - 0093

México, Nuevo León, 64320, Mexico

Location

Local Institution - 0098

Oaxaca City, 68020, Mexico

Location

Local Institution - 0009

Lørenskog, Akershus, 1478, Norway

Location

Local Institution - 0023

Stavanger, Rogaland, 4011, Norway

Location

Local Institution - 0017

Oslo, 0310, Norway

Location

Local Institution - 0249

Coimbra, 3000-075, Portugal

Location

Local Institution - 0170

Brasov, 500283, Romania

Location

Local Institution - 0065

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0066

Craiova, 200542, Romania

Location

Local Institution - 0064

Floresti/ Cluj, 407280, Romania

Location

Local Institution - 0188

Badajoz, 06071, Spain

Location

Local Institution - 0201

Barcelona, 08035, Spain

Location

Local Institution - 0151

Donostia / San Sebastian, 20014, Spain

Location

Local Institution - 0153

Granada, 18012, Spain

Location

Local Institution - 0150

Madrid, 28009, Spain

Location

Local Institution - 0152

Valencia, 46026, Spain

Location

Local Institution - 0010

Gothenburg, 41345, Sweden

Location

Local Institution - 0011

Lund, 221 85, Sweden

Location

Local Institution - 0012

Solna, 171 64, Sweden

Location

Local Institution - 0085

Basel, 4031, Switzerland

Location

Local Institution - 0087

Chur, 7000, Switzerland

Location

Local Institution - 0090

Zurich, 8091, Switzerland

Location

Local Institution - 0101

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Local Institution - 0102

Bristol, BS2 8ED, United Kingdom

Location

Local Institution - 0187

Glasgow, G12 0YN, United Kingdom

Location

Local Institution - 0154

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Local Institution - 0232

Oxford, OX3 7LE, United Kingdom

Location

Local Institution - 0127

Southampton, SO16 0YD, United Kingdom

Location

Related Publications (1)

• Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Munoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. Nat Med. 2025 Dec;31(12):4301-4309. doi: 10.1038/s41591-025-04032-8. Epub 2025 Oct 18.

  PMID: 41109920 DERIVED

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: October 19, 2021
• Primary Completion: December 16, 2024
• Study Completion: April 2, 2025
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Locations

CZ (4); AU (12); FR (7); DE (12); RO (4); NO (3); BR (10); PT (1); ES (6); SE (3); FI (3); GB (6); CL (3); BE (4); CH (3); GR (3); CN (23); ME (4); US (43); IT (7); AR (5); DK (4); IL (4); CA (7)