A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
NCT ID: NCT05625399
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
579 participants
INTERVENTIONAL
2023-03-06
2027-11-18
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
NONE
Study Groups
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Nivolumab + Relatlimab FDC SC
Nivolumab + Relatlimab
Specified dose on specified days
rHuPH20
Specified dose on specified days
Nivolumab + Relatlimab FDC IV
Nivolumab + Relatlimab
Specified dose on specified days
Interventions
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Nivolumab + Relatlimab
Specified dose on specified days
rHuPH20
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
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 - 0125
Phoenix, Arizona, United States
Local Institution - 0189
Springdale, Arkansas, United States
Local Institution - 0098
Los Angeles, California, United States
Local Institution - 0093
Orange, California, United States
Local Institution - 0123
Stanford, California, United States
Local Institution - 0113
Englewood, Colorado, United States
Local Institution - 0114
Jacksonville, Florida, United States
Local Institution - 0146
Baltimore, Maryland, United States
Local Institution - 0071
Rochester, Minnesota, United States
Local Institution - 0013
Omaha, Nebraska, United States
Local Institution - 0169
Cleveland, Ohio, United States
Local Institution - 0139
Easton, Pennsylvania, United States
Local Institution - 0124
Philadelphia, Pennsylvania, United States
Local Institution - 0122
Murray, Utah, United States
Local Institution - 0115
Fairfax, Virginia, United States
Local Institution - 0050
Coffs Harbour, New South Wales, Australia
Local Institution - 0175
Orange, New South Wales, Australia
Local Institution - 0172
Port Macquarie, New South Wales, Australia
Local Institution - 0118
Wagga Wagga, New South Wales, Australia
Local Institution - 0184
Waratah, New South Wales, Australia
Local Institution - 0033
Westmead, New South Wales, Australia
Local Institution - 0055
Wollstonecraft, New South Wales, Australia
Local Institution - 0090
Birtinya, Queensland, Australia
Local Institution - 0008
Bendigo, Victoria, Australia
Local Institution - 0059
Box Hill, Victoria, Australia
Local Institution - 0154
Heidelberg, Victoria, Australia
Local Institution - 0030
Melbourne, Victoria, Australia
Local Institution - 0109
Traralgon, Victoria, Australia
Local Institution - 0106
Nedlands, Western Australia, Australia
Local Institution - 0161
Nedlands, Western Australia, Australia
Local Institution - 0027
Graz, , Austria
Local Institution - 0029
Salzburg, , Austria
Local Institution - 0168
Sankt Pölten, , Austria
Local Institution - 0037
Vienna, , Austria
Local Institution - 0072
Brussels, , Belgium
Local Institution - 0078
Charleroi, , Belgium
Local Institution - 0016
Liège, , Belgium
Local Institution - 0177
Fortaleza, Ceará, Brazil
Local Institution - 0180
Vitória, Espírito Santo, Brazil
Local Institution - 0107
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0025
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0031
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0058
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0002
Porto Alegrelegre, Rio Grande do Sul, Brazil
Local Institution - 0159
Blumenau, Santa Catarina, Brazil
Local Institution - 0009
Barretos, São Paulo, Brazil
Local Institution - 0018
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0110
Rio de Janeiro, , Brazil
Local Institution - 0130
São Paulo, , Brazil
Local Institution - 0141
Calgary, Alberta, Canada
Local Institution - 0121
Hamilton, Ontario, Canada
Local Institution - 0096
Ottawa, Ontario, Canada
Local Institution - 0116
Toronto, Ontario, Canada
Local Institution - 0103
Québec, Quebec, Canada
Local Institution - 0178
Port Montt, Los Lagos Region, Chile
Local Institution - 0119
Santiago, Providencia, Chile
Local Institution - 0143
Temuco, Región de la Araucanía, Chile
Local Institution - 0028
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0140
Recoleta, Santiago Metropolitan, Chile
Local Institution - 0144
Santiago, Santiago Metropolitan, Chile
Local Institution - 0010
Santiago, Santiago Metropolitan, Chile
Local Institution - 0074
Santiago, Santiago Metropolitan, Chile
Local Institution - 0017
Santiago, , Chile
Local Institution - 0083
Prague, NY, Czechia
Local Institution - 0094
Hradec Králové, , Czechia
Local Institution - 0091
Olomouc, , Czechia
Local Institution - 0082
Ostrava Poruba, , Czechia
Local Institution - 0095
Prague, , Czechia
Local Institution - 0164
Helsinki, , Finland
Local Institution - 0167
Tampere, , Finland
Local Institution - 0162
Turku, , Finland
Local Institution - 0108
Toulouse, Cedex 9, France
Local Institution - 0127
Chambray-lès-Tours, Indre-Et-Loire, France
Local Institution - 0111
Lille, Nord, France
Local Institution - 0063
Nantes, OH, France
Local Institution - 0061
Villejuif, Val-De-Marne, France
Local Institution - 0007
Amiens, , France
Local Institution - 0128
Bayonne, , France
Local Institution - 0022
Bordeaux, , France
Local Institution - 0129
Clermont-Ferrand, , France
Local Institution - 0046
Dijon, , France
Local Institution - 0117
Marseille, , France
Local Institution - 0052
Pierre-Bénite, , France
Local Institution - 0089
Rennes, , France
Local Institution - 0099
Rouen, , France
Local Institution - 0034
Paris, Île-de-France Region, France
Local Institution - 0101
Heidelberg, Baden-Wurttemberg, Germany
Local Institution - 0079
Ulm, Baden-Wurttemberg, Germany
Local Institution - 0011
Regensburg, Bavaria, Germany
Local Institution - 0003
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0060
Berlin, , Germany
Local Institution - 0038
Buxtehude, , Germany
Local Institution - 0136
Dortmund, , Germany
Local Institution - 0039
Erfurt, , Germany
Local Institution - 0049
Essen, , Germany
Local Institution - 0166
Frankfurt am Main, , Germany
Local Institution - 0065
Giessen, , Germany
Local Institution - 0135
Göttingen, , Germany
Local Institution - 0138
Hamburg, , Germany
Local Institution - 0137
Ludwigshafen, , Germany
Local Institution - 0165
Marburg, , Germany
Local Institution - 0044
Minden, , Germany
Local Institution - 0112
Nuremberg, , Germany
Local Institution - 0053
Rostock, , Germany
Local Institution - 0081
Tübingen, , Germany
Local Institution - 0026
Afula, , Israel
Local Institution - 0054
Jerusalem, , Israel
Local Institution - 0102
Petah-Tikvah, , Israel
Local Institution - 0173
Tel Aviv, , Israel
Local Institution - 0035
Tel Litwinsky, , Israel
Local Institution - 0051
Bari, , Italy
Local Institution - 0077
Genova, , Italy
Local Institution - 0170
Milan, , Italy
Local Institution - 0084
Napoli, , Italy
Local Institution - 0032
Perugia, , Italy
Local Institution - 0064
Roma, , Italy
Local Institution - 0014
Siena, , Italy
Local Institution - 0163
Bodø, , Norway
Local Institution - 0156
Grålum, , Norway
Local Institution - 0158
Lørenskog, , Norway
Local Institution - 0155
Oslo, , Norway
Local Institution - 0171
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0021
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0005
Opole, Opole Voivodeship, Poland
Local Institution - 0015
Poznan, Wiekopolskie, Poland
Local Institution - 0066
Warsaw, , Poland
Local Institution - 0012
Donostia / San Sebastian, Gipuzkoa, Spain
Local Institution - 0086
A Coruña, , Spain
Local Institution - 0134
Badalona, , Spain
Local Institution - 0047
Barcelona, , Spain
Local Institution - 0024
Barcelona, , Spain
Local Institution - 0153
Jaén, , Spain
Local Institution - 0045
Las Palmas de Gran Canaria, , Spain
Local Institution - 0040
Madrid, , Spain
Local Institution - 0126
Madrid, , Spain
Local Institution - 0004
Madrid, , Spain
Local Institution - 0056
Madrid, , Spain
Local Institution - 0006
Seville, , Spain
Local Institution - 0041
Valencia, , Spain
Local Institution - 0043
Valencia, , Spain
Local Institution - 0151
Valencia, , Spain
Local Institution - 0062
Solna, Stockholm County, Sweden
Local Institution - 0097
Lund, , Sweden
Local Institution - 0092
Bern, , Switzerland
Local Institution - 0080
Chur, , Switzerland
Local Institution - 0105
Lausanne, , Switzerland
Local Institution - 0088
London, Greater London, United Kingdom
Local Institution - 0068
Headington, Oxford, Oxfordshire, United Kingdom
Local Institution - 0120
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2022-000575-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1274-0193
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA224-127
Identifier Type: -
Identifier Source: org_study_id
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