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A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
Official title: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
579
Start Date
2023-03-06
Completion Date
2027-11-18
Last Updated
2025-08-24
Healthy Volunteers
No
Conditions
Interventions
Nivolumab + Relatlimab
Specified dose on specified days
rHuPH20
Specified dose on specified days
Locations (149)
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
Naples, 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