A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

NCT03470922 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: CA224-0472024-510913-13
• Study Type: interventional
• Target: 714
• Locations: 24 countries
• Sites: 121

Brief Summary

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

Conditions

Melanoma

Keywords

Cancer; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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.

  From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Secondary Outcomes (2)

• Overall Survival (OS)

  From randomization to the date of death (up to approximately 3 years)

• Overall Response Rate (ORR)

  From randomization up to approximately 3 years

Other Outcomes (6)

• 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 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 Adverse Events (AEs) Leading to Discontinuation

  From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Study Arms (2)

Arm A: Relatlimab + Nivolumab

EXPERIMENTAL

Combination

Biological: Relatlimab; Biological: Nivolumab

Arm B: Nivolumab

EXPERIMENTAL

Monotherapy

Biological: Nivolumab

Interventions

Relatlimab BIOLOGICAL

Specified dose on specified day

Arm A: Relatlimab + Nivolumab

Nivolumab BIOLOGICAL

Specified dose on specified days

Arm A: Relatlimab + Nivolumab; Arm B: Nivolumab

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (127)

Local Institution - 0010

Tucson, Arizona, 85724-5024, United States

Location

Local Institution - 0020

Los Angeles, California, 90095, United States

Location

Coastal Integrative Cancer Care

San Luis Obispo, California, 93401, United States

Location

Local Institution - 0116

Santa Barbara, California, 93105, United States

Location

Local Institution - 0012

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

Location

Local Institution - 0013

Jacksonville, Florida, 32224, United States

Location

Local Institution - 0117

Orlando, Florida, 32806, United States

Location

Local Institution - 0007

Tampa, Florida, 33612, United States

Location

Local Institution - 0038

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0016

Chicago, Illinois, 60611, United States

Location

Local Institution - 0114

Fort Wayne, Indiana, 46804, United States

Location

Local Institution - 0077

Baltimore, Maryland, 21237, United States

Location

Local Institution - 0120

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0014

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0134

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0015

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0009

Minneapolis, Minnesota, 55407, United States

Location

Local Institution - 0011

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0018

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0019

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 0076

Dallas, Texas, 75246, United States

Location

Local Institution - 0008

Houston, Texas, 77030, United States

Location

Local Institution - 0135

Buenos Aires, Distrito Federal, 1121, Argentina

Location

Local Institution - 0002

Capital Federal, Distrito Federal, C1280AEB, Argentina

Location

Local Institution - 0004

Buenos Aires, 1199, Argentina

Location

Local Institution - 0003

Buenos Aires, 1426, Argentina

Location

Local Institution - 0005

Buenos Aires, 4102-4200, Argentina

Location

Local Institution - 0042

North Sydney, New South Wales, 2060, Australia

Location

Local Institution - 0043

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0041

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0045

Southport, Queensland, 4215, Australia

Location

Local Institution - 0133

Bedford Park, South Australia, 5042, Australia

Location

Local Institution - 0044

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0036

Graz, Styria, 8036, Austria

Location

Local Institution - 0037

Salzburg, 5020, Austria

Location

Local Institution - 0035

Vienna, 1090, Austria

Location

Local Institution - 0047

Brussels, 1090, Belgium

Location

Local Institution - 0049

Brussels, 1200, Belgium

Location

Local Institution - 0048

Ghent, 9000, Belgium

Location

Local Institution - 0058

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0057

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

Location

Local Institution - 0061

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

Location

Local Institution - 0073

Santa Cruz do Sul, Rio Grande do Sul, 96810-110, Brazil

Location

Local Institution - 0063

São Paulo, São Paulo, 05651-901, Brazil

Location

Local Institution - 0059

Rio de Janiro, 20220-410, Brazil

Location

Local Institution - 0060

São Paulo, 01246-000, Brazil

Location

Local Institution - 0062

São Paulo, 01509-010, Brazil

Location

Local Institution - 0124

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Local Institution - 0068

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0128

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0123

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0075

Montreal, Quebec, H4A 3J1, Canada

Location

Local Institution - 0001

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0096

Medellín, Antioquia, 050030, Colombia

Location

Local Institution - 0095

Bogotá, 110321, Colombia

Location

Local Institution - 0105

Aarhus N, Central Jutland, 8200, Denmark

Location

Local Institution - 0103

Herlev, 2730, Denmark

Location

Local Institution - 0104

Odense, 5000, Denmark

Location

Local Institution - 0100

Helsinki, Uusimaa, 00290, Finland

Location

Local Institution - 0102

Oulu, 90220, Finland

Location

Local Institution - 0119

Tampere, 33521, Finland

Location

Local Institution - 0101

Turku, 20520, Finland

Location

Local Institution - 0084

Rennes, Ille-et-Vilaine, 35042, France

Location

Local Institution - 0079

Amiens, Somme, 80000, France

Location

Local Institution - 0080

Bordeaux, 33075, France

Location

Local Institution - 0085

Lille, 59000, France

Location

Local Institution - 0081

Marseille, 13011, France

Location

Local Institution - 0083

Paris, 75010, France

Location

Local Institution - 0078

Pierre-Bénite, 69310, France

Location

Local Institution - 0082

Poitiers, 86000, France

Location

Local Institution - 0132

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Local Institution - 0131

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Local Institution - 0071

Quedlinburg, Saxony-Anhalt, 06484, Germany

Location

Local Institution - 0032

Buxtehude, 21614, Germany

Location

Local Institution - 0029

Cologne, 50937, Germany

Location

Local Institution - 0030

Erfurt, 99089, Germany

Location

Local Institution - 0027

Essen, 45147, Germany

Location

Local Institution - 0033

Hanover, 30625, Germany

Location

Local Institution - 0074

Homburg / Saar, 66421, Germany

Location

Local Institution - 0028

Lübeck, 23538, Germany

Location

Local Institution - 0072

Mannheim, 68167, Germany

Location

Local Institution - 0034

München, 81675, Germany

Location

Local Institution - 0031

Würzburg, 97080, Germany

Location

Local Institution - 0064

Athens, 11526, Greece

Location

Local Institution - 0065

Thessaloniki, 54622, Greece

Location

Local Institution - 0086

Haifa, 3109601, Israel

Location

Local Institution - 0088

Jerusalem, 91120, Israel

Location

Local Institution - 0087

Ramat Gan, 52621, Israel

Location

Local Institution - 0111

Turin, Piedmont, 10126, Italy

Location

Local Institution - 0109

Bergamo, 24127, Italy

Location

Local Institution - 0108

Milan, 20133, Italy

Location

Local Institution - 0106

Napoli, 80131, Italy

Location

Local Institution - 0110

Padua, 35128, Italy

Location

Local Institution - 0107

Siena, 53100, Italy

Location

Local Institution - 0094

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0091

Monterrey, Nuevo León, 64060, Mexico

Location

Local Institution - 0093

Cancún, Quintana Roo, 77500, Mexico

Location

Local Institution - 0092

Mérida, Yucatán, 97130, Mexico

Location

Local Institution - 0129

Veracruz, 91900, Mexico

Location

Local Institution - 0090

Dunedin, 9012, New Zealand

Location

Local Institution - 0125

Hamilton, 3240, New Zealand

Location

Local Institution - 0089

Tauranga, 3112, New Zealand

Location

Local Institution - 0121

Oslo, 0310, Norway

Location

Local Institution - 0040

Poznan, 60-780, Poland

Location

Local Institution - 0039

Warsaw, 02-781, Poland

Location

Local Institution - 0070

Cluj-Napoca, Cluj, 400015, Romania

Location

Local Institution - 0066

Bucharest,  022328, Romania

Location

Local Institution - 0067

Craiova, 200542, Romania

Location

Local Institution - 0069

Iași, 700483, Romania

Location

Local Institution - 0113

Krasnodar, 350040, Russia

Location

Local Institution - 0127

Krasnoyarsk, 660133, Russia

Location

Local Institution - 0112

Moscow, 115478, Russia

Location

Local Institution - 0023

A Coruña, 15006, Spain

Location

Local Institution - 0024

Barcelona, 08035, Spain

Location

Local Institution - 0025

Barcelona, 08036, Spain

Location

Local Institution - 0026

Madrid, 28034, Spain

Location

Local Institution - 0021

San Sabastian Gipuzkoa, 20014, Spain

Location

Local Institution - 0022

Seville, 41009, Spain

Location

Local Institution - 0098

Gothenburg, 413 45, Sweden

Location

Local Institution - 0099

Lund, 221 85, Sweden

Location

Local Institution - 0118

Solna, 171 64, Sweden

Location

Local Institution - 0122

Uppsala, 751 85, Sweden

Location

Local Institution - 0052

Bristol, Avon, BS2 8ED, United Kingdom

Location

Local Institution - 0054

Glasgow, Dumfries & Galloway, G12 0YN, United Kingdom

Location

Local Institution - 0056

Swansea, Glamorgan, SA2 8QA, United Kingdom

Location

Local Institution - 0051

London, Greater London, SE1 9RT, United Kingdom

Location

Local Institution - 0126

Inverness, Inverness-shire, IV2 3UJ, United Kingdom

Location

Related Publications (7)

• Regan MM, Ascierto PA MD, Lipson EJ, Palaia J, Moshyk A, Selvan A, Lao CD, Atkins MB MD, McDermott DF, Potluri R, Ranjan S, Bilthare S, Long GV, Stephen Hodi F, Tawbi H, Schadendorf D. Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047. J Immunother Cancer. 2025 Sep 12;13(9):e012747. doi: 10.1136/jitc-2025-012747.

  PMID: 40940136 DERIVED

• Lipson EJ, Stephen Hodi F, Tawbi H, Schadendorf D, Ascierto PA, Matamala L, Gutierrez EC, Rutkowski P, Gogas HJ, Lao CD, Menezes JJ, Dalle S, Arance A, Gaudy-Marqueste C, Chen B, Jackson W, Mukherjee S, Dolfi S, Long GV. Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update. Eur J Cancer. 2025 Jul 25;225:115547. doi: 10.1016/j.ejca.2025.115547. Epub 2025 Jun 3.

  PMID: 40513285 DERIVED

• Tawbi HA, Hodi FS, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas H, Lao CD, Janoski De Menezes J, Dalle S, Arance AM, Grob JJ, Ratto B, Rodriguez S, Mazzei A, Dolfi S, Long GV. Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047. J Clin Oncol. 2025 May;43(13):1546-1552. doi: 10.1200/JCO.24.01124. Epub 2024 Dec 13.

  PMID: 39671533 DERIVED

• Long GV, Stephen Hodi F, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Salman P, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, Janoski De Menezes J, Dalle S, Arance A, Grob JJ, Keidel S, Shaikh A, Sobiesk AM, Dolfi S, Tawbi HA. Overall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma. NEJM Evid. 2023 Apr;2(4):EVIDoa2200239. doi: 10.1056/EVIDoa2200239. Epub 2023 Mar 22.

  PMID: 38320023 DERIVED

• Schadendorf D, Tawbi H, Lipson EJ, Stephen Hodi F, Rutkowski P, Gogas H, Lao CD, Grob JJ, Moshyk A, Lord-Bessen J, Hamilton M, Guo S, Shi L, Keidel S, Long GV. Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial. Eur J Cancer. 2023 Jul;187:164-173. doi: 10.1016/j.ejca.2023.03.014. Epub 2023 Mar 22.

  PMID: 37167764 DERIVED

• Raschi E, Comito F, Massari F, Gelsomino F. Relatlimab and nivolumab in untreated advanced melanoma: insight into RELATIVITY. Immunotherapy. 2023 Feb;15(2):85-91. doi: 10.2217/imt-2022-0172. Epub 2023 Jan 11.

  PMID: 36628573 DERIVED

• Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.

  PMID: 34986285 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Melanoma; Neoplasms

Interventions

relatlimab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 20, 2018
• Study Start: April 11, 2018
• Primary Completion: January 25, 2021
• Study Completion (Estimated): December 15, 2030
• Last Updated: September 9, 2025
• Results First Posted: March 29, 2022

Record last verified: 2025-08

Locations

FI (4); CL (1); US (22); PL (2); BR (8); FR (8); NZ (3); NO (1); AU (3); DK (3); IL (3); CA (5); IT (6); RO (4); CO (2); RU (3); ES (6); SE (4); GB (5); AR (5); DE (13); BE (3); ME (5); GR (2)