A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
NCT ID: NCT03470922
Last Updated: 2025-09-09
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
714 participants
INTERVENTIONAL
2018-04-11
2030-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A: Relatlimab + Nivolumab
Combination
Relatlimab
Specified dose on specified day
Nivolumab
Specified dose on specified days
Arm B: Nivolumab
Monotherapy
Nivolumab
Specified dose on specified days
Interventions
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Relatlimab
Specified dose on specified day
Nivolumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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 uveal melanoma
* Participants must not have an active, known, or suspected autoimmune disease
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0010
Tucson, Arizona, United States
Local Institution - 0020
Los Angeles, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Local Institution - 0116
Santa Barbara, California, United States
Local Institution - 0012
Washington D.C., District of Columbia, United States
Local Institution - 0013
Jacksonville, Florida, United States
Local Institution - 0117
Orlando, Florida, United States
Local Institution - 0007
Tampa, Florida, United States
Local Institution - 0038
Atlanta, Georgia, United States
Local Institution - 0016
Chicago, Illinois, United States
Local Institution - 0114
Fort Wayne, Indiana, United States
Local Institution - 0077
Baltimore, Maryland, United States
Local Institution - 0120
Baltimore, Maryland, United States
Local Institution - 0014
Boston, Massachusetts, United States
Local Institution - 0134
Boston, Massachusetts, United States
Local Institution - 0015
Ann Arbor, Michigan, United States
Local Institution - 0009
Minneapolis, Minnesota, United States
Local Institution - 0011
Rochester, Minnesota, United States
Local Institution - 0018
Charlotte, North Carolina, United States
Local Institution - 0019
Allentown, Pennsylvania, United States
Local Institution - 0076
Dallas, Texas, United States
Local Institution - 0008
Houston, Texas, United States
Local Institution - 0135
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0002
Capital Federal, Distrito Federal, Argentina
Local Institution - 0004
Buenos Aires, , Argentina
Local Institution - 0003
Buenos Aires, , Argentina
Local Institution - 0005
Buenos Aires, , Argentina
Local Institution - 0042
North Sydney, New South Wales, Australia
Local Institution - 0043
Waratah, New South Wales, Australia
Local Institution - 0041
Greenslopes, Queensland, Australia
Local Institution - 0045
Southport, Queensland, Australia
Local Institution - 0133
Bedford Park, South Australia, Australia
Local Institution - 0044
Murdoch, Western Australia, Australia
Local Institution - 0036
Graz, Styria, Austria
Local Institution - 0037
Salzburg, , Austria
Local Institution - 0035
Vienna, , Austria
Local Institution - 0047
Brussels, , Belgium
Local Institution - 0049
Brussels, , Belgium
Local Institution - 0048
Ghent, , Belgium
Local Institution - 0058
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0057
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0061
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0073
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Local Institution - 0063
São Paulo, São Paulo, Brazil
Local Institution - 0059
Rio de Janiro, , Brazil
Local Institution - 0060
São Paulo, , Brazil
Local Institution - 0062
São Paulo, , Brazil
Local Institution - 0124
Halifax, Nova Scotia, Canada
Local Institution - 0068
Ottawa, Ontario, Canada
Local Institution - 0128
Toronto, Ontario, Canada
Local Institution - 0123
Montreal, Quebec, Canada
Local Institution - 0075
Montreal, Quebec, Canada
Local Institution - 0001
Santiago, Santiago Metropolitan, Chile
Local Institution - 0096
Medellín, Antioquia, Colombia
Local Institution - 0095
Bogotá, , Colombia
Local Institution - 0105
Aarhus N, Central Jutland, Denmark
Local Institution - 0103
Herlev, , Denmark
Local Institution - 0104
Odense, , Denmark
Local Institution - 0100
Helsinki, Uusimaa, Finland
Local Institution - 0102
Oulu, , Finland
Local Institution - 0119
Tampere, , Finland
Local Institution - 0101
Turku, , Finland
Local Institution - 0084
Rennes, Ille-et-Vilaine, France
Local Institution - 0079
Amiens, Somme, France
Local Institution - 0080
Bordeaux, , France
Local Institution - 0085
Lille, , France
Local Institution - 0081
Marseille, , France
Local Institution - 0083
Paris, , France
Local Institution - 0078
Pierre-Bénite, , France
Local Institution - 0082
Poitiers, , France
Local Institution - 0132
Heidelberg, Baden-Wurttemberg, Germany
Local Institution - 0131
Tübingen, Baden-Wurttemberg, Germany
Local Institution - 0071
Quedlinburg, Saxony-Anhalt, Germany
Local Institution - 0032
Buxtehude, , Germany
Local Institution - 0029
Cologne, , Germany
Local Institution - 0030
Erfurt, , Germany
Local Institution - 0027
Essen, , Germany
Local Institution - 0033
Hanover, , Germany
Local Institution - 0074
Homburg / Saar, , Germany
Local Institution - 0028
Lübeck, , Germany
Local Institution - 0072
Mannheim, , Germany
Local Institution - 0034
München, , Germany
Local Institution - 0031
Würzburg, , Germany
Local Institution - 0064
Athens, , Greece
Local Institution - 0065
Thessaloniki, , Greece
Local Institution - 0086
Haifa, , Israel
Local Institution - 0088
Jerusalem, , Israel
Local Institution - 0087
Ramat Gan, , Israel
Local Institution - 0111
Turin, Piedmont, Italy
Local Institution - 0109
Bergamo, , Italy
Local Institution - 0108
Milan, , Italy
Local Institution - 0106
Napoli, , Italy
Local Institution - 0110
Padua, , Italy
Local Institution - 0107
Siena, , Italy
Local Institution - 0094
Zapopan, Jalisco, Mexico
Local Institution - 0091
Monterrey, Nuevo León, Mexico
Local Institution - 0093
Cancún, Quintana Roo, Mexico
Local Institution - 0092
Mérida, Yucatán, Mexico
Local Institution - 0129
Veracruz, , Mexico
Local Institution - 0090
Dunedin, , New Zealand
Local Institution - 0125
Hamilton, , New Zealand
Local Institution - 0089
Tauranga, , New Zealand
Local Institution - 0121
Oslo, , Norway
Local Institution - 0040
Poznan, , Poland
Local Institution - 0039
Warsaw, , Poland
Local Institution - 0070
Cluj-Napoca, Cluj, Romania
Local Institution - 0066
Bucharest, , Romania
Local Institution - 0067
Craiova, , Romania
Local Institution - 0069
Iași, , Romania
Local Institution - 0113
Krasnodar, , Russia
Local Institution - 0127
Krasnoyarsk, , Russia
Local Institution - 0112
Moscow, , Russia
Local Institution - 0023
A Coruña, , Spain
Local Institution - 0024
Barcelona, , Spain
Local Institution - 0025
Barcelona, , Spain
Local Institution - 0026
Madrid, , Spain
Local Institution - 0021
San Sabastian Gipuzkoa, , Spain
Local Institution - 0022
Seville, , Spain
Local Institution - 0098
Gothenburg, , Sweden
Local Institution - 0099
Lund, , Sweden
Local Institution - 0118
Solna, , Sweden
Local Institution - 0122
Uppsala, , Sweden
Local Institution - 0052
Bristol, Avon, United Kingdom
Local Institution - 0054
Glasgow, Dumfries & Galloway, United Kingdom
Local Institution - 0056
Swansea, Glamorgan, United Kingdom
Local Institution - 0051
London, Greater London, United Kingdom
Local Institution - 0126
Inverness, Inverness-shire, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-510913-13
Identifier Type: OTHER
Identifier Source: secondary_id
CA224-047
Identifier Type: -
Identifier Source: org_study_id
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