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

August 19, 2025 updated by: Bristol-Myers Squibb

A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

714

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1199
        • Local Institution - 0004
      • Buenos Aires, Argentina, 4102-4200
        • Local Institution - 0005
      • Buenos Aires, Argentina, 1426
        • Local Institution - 0003
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, 1121
        • Local Institution - 0135
      • Capital Federal, Distrito Federal, Argentina, C1280AEB
        • Local Institution - 0002
  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Local Institution - 0042
      • Waratah, New South Wales, Australia, 2298
        • Local Institution - 0043
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution - 0041
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0045
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Local Institution - 0133
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0044
  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 0037
      • Vienna, Austria, 1090
        • Local Institution - 0035
    • Styria
      • Graz, Styria, Austria, 8036
        • Local Institution - 0036
  • Belgium
      • Brussels, Belgium, 1090
        • Local Institution - 0047
      • Brussels, Belgium, 1200
        • Local Institution - 0049
      • Ghent, Belgium, 9000
        • Local Institution - 0048
  • Brazil
      • Rio de Janiro, Brazil, 20220-410
        • Local Institution - 0059
      • São Paulo, Brazil, 01246-000
        • Local Institution - 0060
      • São Paulo, Brazil, 01509-010
        • Local Institution - 0062
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution - 0058
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Local Institution - 0057
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Local Institution - 0061
      • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96810-110
        • Local Institution - 0073
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05651-901
        • Local Institution - 0063
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Local Institution - 0124
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0068
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0128
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0123
      • Montreal, Quebec, Canada, H4A 3J1
        • Local Institution - 0075
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0001
  • Colombia
      • Bogotá, Colombia, 110321
        • Local Institution - 0095
    • Antioquia
      • Medellín, Antioquia, Colombia, 050030
        • Local Institution - 0096
  • Denmark
      • Herlev, Denmark, 2730
        • Local Institution - 0103
      • Odense, Denmark, 5000
        • Local Institution - 0104
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Local Institution - 0105
  • Finland
      • Oulu, Finland, 90220
        • Local Institution - 0102
      • Tampere, Finland, 33521
        • Local Institution - 0119
      • Turku, Finland, 20520
        • Local Institution - 0101
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Local Institution - 0100
  • France
      • Bordeaux, France, 33075
        • Local Institution - 0080
      • Lille, France, 59000
        • Local Institution - 0085
      • Marseille, France, 13011
        • Local Institution - 0081
      • Paris, France, 75010
        • Local Institution - 0083
      • Pierre-Bénite, France, 69310
        • Local Institution - 0078
      • Poitiers, France, 86000
        • Local Institution - 0082
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Local Institution - 0084
    • Somme
      • Amiens, Somme, France, 80000
        • Local Institution - 0079
  • Germany
      • Buxtehude, Germany, 21614
        • Local Institution - 0032
      • Cologne, Germany, 50937
        • Local Institution - 0029
      • Erfurt, Germany, 99089
        • Local Institution - 0030
      • Essen, Germany, 45147
        • Local Institution - 0027
      • Hanover, Germany, 30625
        • Local Institution - 0033
      • Homburg / Saar, Germany, 66421
        • Local Institution - 0074
      • Lübeck, Germany, 23538
        • Local Institution - 0028
      • Mannheim, Germany, 68167
        • Local Institution - 0072
      • München, Germany, 81675
        • Local Institution - 0034
      • Würzburg, Germany, 97080
        • Local Institution - 0031
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Local Institution - 0132
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Local Institution - 0131
    • Saxony-Anhalt
      • Quedlinburg, Saxony-Anhalt, Germany, 06484
        • Local Institution - 0071
  • Greece
      • Athens, Greece, 11526
        • Local Institution - 0064
      • Thessaloniki, Greece, 54622
        • Local Institution - 0065
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution - 0086
      • Jerusalem, Israel, 91120
        • Local Institution - 0088
      • Ramat Gan, Israel, 52621
        • Local Institution - 0087
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 0109
      • Milan, Italy, 20133
        • Local Institution - 0108
      • Napoli, Italy, 80131
        • Local Institution - 0106
      • Padua, Italy, 35128
        • Local Institution - 0110
      • Siena, Italy, 53100
        • Local Institution - 0107
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Local Institution - 0111
  • Mexico
      • Veracruz, Mexico, 91900
        • Local Institution - 0129
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Local Institution - 0094
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Local Institution - 0091
    • Quintana Roo
      • Cancún, Quintana Roo, Mexico, 77500
        • Local Institution - 0093
    • Yucatán
      • Mérida, Yucatán, Mexico, 97130
        • Local Institution - 0092
  • New Zealand
      • Dunedin, New Zealand, 9012
        • Local Institution - 0090
      • Hamilton, New Zealand, 3240
        • Local Institution - 0125
      • Tauranga, New Zealand, 3112
        • Local Institution - 0089
  • Norway
      • Oslo, Norway, 0310
        • Local Institution - 0121
  • Poland
      • Poznan, Poland, 60-780
        • Local Institution - 0040
      • Warsaw, Poland, 02-781
        • Local Institution - 0039
  • Romania
      • Bucharest, Romania,  022328
        • Local Institution - 0066
      • Craiova, Romania, 200542
        • Local Institution - 0067
      • Iași, Romania, 700483
        • Local Institution - 0069
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Local Institution - 0070
  • Russia
      • Krasnodar, Russia, 350040
        • Local Institution - 0113
      • Krasnoyarsk, Russia, 660133
        • Local Institution - 0127
      • Moscow, Russia, 115478
        • Local Institution - 0112
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0023
      • Barcelona, Spain, 08035
        • Local Institution - 0024
      • Barcelona, Spain, 08036
        • Local Institution - 0025
      • Madrid, Spain, 28034
        • Local Institution - 0026
      • San Sabastian Gipuzkoa, Spain, 20014
        • Local Institution - 0021
      • Seville, Spain, 41009
        • Local Institution - 0022
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Local Institution - 0098
      • Lund, Sweden, 221 85
        • Local Institution - 0099
      • Solna, Sweden, 171 64
        • Local Institution - 0118
      • Uppsala, Sweden, 751 85
        • Local Institution - 0122
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8ED
        • Local Institution - 0052
    • Dumfries & Galloway
      • Glasgow, Dumfries & Galloway, United Kingdom, G12 0YN
        • Local Institution - 0054
    • Glamorgan
      • Swansea, Glamorgan, United Kingdom, SA2 8QA
        • Local Institution - 0056
    • Greater London
      • London, Greater London, United Kingdom, SE1 9RT
        • Local Institution - 0051
    • Inverness-shire
      • Inverness, Inverness-shire, United Kingdom, IV2 3UJ
        • Local Institution - 0126
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-5024
        • Local Institution - 0010
    • California
      • Los Angeles, California, United States, 90095
        • Local Institution - 0020
      • San Luis Obispo, California, United States, 93401
        • Coastal Integrative Cancer Care
      • Santa Barbara, California, United States, 93105
        • Local Institution - 0116
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Local Institution - 0012
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0013
      • Orlando, Florida, United States, 32806
        • Local Institution - 0117
      • Tampa, Florida, United States, 33612
        • Local Institution - 0007
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0038
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0016
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Local Institution - 0114
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Local Institution - 0077
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0120
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0014
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0134
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0015
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Local Institution - 0009
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0011
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0018
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0019
    • Texas
      • Dallas, Texas, United States, 75246
        • Local Institution - 0076
      • Houston, Texas, United States, 77030
        • Local Institution - 0008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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.
From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 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").
From randomization to the date of death (up to approximately 3 years)
Overall Response Rate (ORR)
Time Frame: 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).
From randomization up to approximately 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Experiencing Adverse Events (AEs)
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: 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.
From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
The Number of Participant Deaths in the Study
Time Frame: From first dose up to approximately 33 months
The number of participant deaths in the study.
From first dose up to approximately 33 months
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
Time Frame: 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.
From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests
Time Frame: 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.
From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Actual)

January 25, 2021

Study Completion (Estimated)

December 15, 2030

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-047
  • 2024-510913-13 (Other Identifier: EU CT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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