A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT05625399
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 570
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab + Relatlimab FDC SC rHuPH20 - Nivolumab + Relatlimab FDC IV Nivolumab + Relatlimab - Nivolumab + Relatlimab FDC SC Nivolumab + Relatlimab -
- Primary Outcome Measures
Name Time Method Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab Up to 28 days Cavgd28 of Relatlimab Up to 28 days Trough serum concentration at steady state (Cminss) of Nivolumab Up to 4 months Cminss of Relatlimab Up to 4 months
- Secondary Outcome Measures
Name Time Method Overall Survival Up to approximately 3 years Number of Participants with Adverse Events (AEs) Up to approximately 3 years Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab Up to 28 days Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab Up to 28 days Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab Up to 28 days Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1 Up to approximately 3 years Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab Up to 4 months Disease Control Rate (DCR) by BICR per RECIST v1.1 Up to approximately 3 years Time to Response (TTR), by BICR per RECIST v1.1 Up to approximately 3 years DOR by Investigator per RECIST v1.1 Up to approximately 3 years Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab Up to 4 months Duration of Response (DOR) by BICR per RECIST v1.1 Up to approximately 3 years Objective Response Rate (ORR) by Investigator per RECIST v1.1 Up to approximately 3 years TTR by Investigator per RECIST v1.1 Up to approximately 3 years Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS) Up to approximately 3 years DCR by Investigator per RECIST v1.1 Up to approximately 3 years Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1 Up to approximately 3 years
Trial Locations
- Locations (149)
Local Institution - 0086
🇪🇸A Coruna, Spain
Local Institution - 0134
🇪🇸Badalona, Spain
Local Institution - 0047
🇪🇸Barcelona, Spain
Local Institution - 0024
🇪🇸Barcelona, Spain
Local Institution - 0153
🇪🇸Jaen, Spain
Local Institution - 0044
🇩🇪Minden, Germany
Local Institution - 0112
🇩🇪Nuernberg, Germany
Local Institution - 0053
🇩🇪Rostock, Germany
Local Institution - 0105
🇨ðŸ‡Lausanne, Switzerland
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 - 0059
🇦🇺Box Hill, Victoria, Australia
Local Institution - 0154
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0090
🇦🇺Birtinya, Queensland, Australia
Local Institution - 0109
🇦🇺Traralgon, Victoria, Australia
Local Institution - 0008
🇦🇺Bendigo, Victoria, Australia
Local Institution - 0106
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0029
🇦🇹Salzburg, Austria
Local Institution - 0168
🇦🇹St. Polten, Austria
Local Institution - 0037
🇦🇹Wien, Austria
Local Institution - 0030
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0161
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0027
🇦🇹Graz, Austria
Local Institution - 0072
🇧🇪Brussels, Belgium
Local Institution - 0078
🇧🇪Charleroi, Belgium
Local Institution - 0016
🇧🇪Liege, Belgium
Local Institution - 0177
🇧🇷Fortaleza, Ce, Brazil
Local Institution - 0180
🇧🇷Vitoria, ES, Brazil
Local Institution - 0107
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0025
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Local Institution - 0002
🇧🇷Porto Alegrelegre, 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 - 0009
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0007
🇫🇷Amiens, France
Local Institution - 0018
🇧🇷Sao Jose do Rio Preto, Sao Paulo, Brazil
Local Institution - 0159
🇧🇷Blumenau, SC, Brazil
Local Institution - 0110
🇧🇷Rio De Janeiro, Brazil
Local Institution - 0128
🇫🇷Bayonne, France
Local Institution - 0130
🇧🇷Sao Paulo, Brazil
Local Institution - 0141
🇨🇦Calgary, Alberta, Canada
Local Institution - 0121
🇨🇦Hamilton, Ontario, Canada
Local Institution - 0096
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0022
🇫🇷Bordeaux, France
Local Institution - 0116
🇨🇦Toronto, Ontario, Canada
Local Institution - 0103
🇨🇦Quebec, Canada
Local Institution - 0143
🇨🇱Temuco, Araucania, Chile
Local Institution - 0178
🇨🇱Puerto Montt, Los Lagos, Chile
Local Institution - 0140
🇨🇱Recoleta, Metropolitana, Chile
Local Institution - 0144
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0010
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0074
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0119
🇨🇱Santiago de Chile, Providencia, Chile
Local Institution - 0028
🇨🇱Vina Del Mar, Valparaiso, Chile
Local Institution - 0017
🇨🇱Santiago, Chile
Local Institution - 0083
🇨🇿Prague, NY, Czechia
Local Institution - 0094
🇨🇿Hradec Kralove, 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 - 0034
🇫🇷Paris, Ile De France, France
Local Institution - 0127
🇫🇷Chambray-les-Tours, Indre-Et-Loire, France
Local Institution - 0111
🇫🇷Lille, Nord, France
Local Institution - 0063
🇫🇷Nantes Cedex 01, OH, France
Local Institution - 0061
🇫🇷Villejuif Cedex, Val-De-Marne, France
Local Institution - 0129
🇫🇷Clermont Ferrand Cedex 1, France
Local Institution - 0046
🇫🇷Dijon, France
Local Institution - 0117
🇫🇷Marseille, France
Local Institution - 0052
🇫🇷Pierre-Benite, France
Local Institution - 0089
🇫🇷Rennes Cedex, France
Local Institution - 0099
🇫🇷Rouen, France
Local Institution - 0101
🇩🇪Heidelberg, Baden-Wurttemberg, Germany
Local Institution - 0079
🇩🇪Ulm, Baden-Wurttemberg, Germany
Local Institution - 0011
🇩🇪Regensburg, Bayern, Germany
Local Institution - 0003
🇩🇪Luebeck, 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
🇩🇪Goettingen, Germany
Local Institution - 0138
🇩🇪Hamburg, Germany
Local Institution - 0137
🇩🇪Ludwigshafen, Germany
Local Institution - 0165
🇩🇪Marburg, Germany
Local Institution - 0081
🇩🇪Tuebingen, Germany
Local Institution - 0026
🇮🇱Afula, Israel
Local Institution - 0054
🇮🇱Jerusalem, Israel
Local Institution - 0102
🇮🇱Petah-Tikvah, Israel
Local Institution - 0035
🇮🇱Tel Hashomer, Israel
Local Institution - 0173
🇮🇱Tel-Aviv, 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
🇳🇴Bodo, Norway
Local Institution - 0156
🇳🇴Gralum, Norway
Local Institution - 0158
🇳🇴Lørenskog, Norway
Local Institution - 0155
🇳🇴Oslo, Norway
Local Institution - 0171
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Local Institution - 0021
🇵🇱Krakow, Malopolskie, Poland
Local Institution - 0005
🇵🇱Opole, Opolskie, Poland
Local Institution - 0015
🇵🇱Poznan, Wiekopolskie, Poland
Local Institution - 0066
🇵🇱Warszawa, Poland
Local Institution - 0012
🇪🇸Donostia, Gipuzkoa, Spain
Local Institution - 0045
🇪🇸Las Palmas de Gran Canaria, Spain
Local Institution - 0040
🇪🇸Madrid, Spain
Local Institution - 0126
🇪🇸Madrid, Spain
Local Institution - 0006
🇪🇸Sevilla, Spain
Local Institution - 0041
🇪🇸Valencia, Spain
Local Institution - 0004
🇪🇸Madrid, Spain
Local Institution - 0056
🇪🇸Madrid, Spain
Local Institution - 0043
🇪🇸Valencia, Spain
Local Institution - 0151
🇪🇸Valencia, Spain
Local Institution - 0062
🇸🇪Solna, Stockholm, Sweden
Local Institution - 0097
🇸🇪Lund, Sweden
Local Institution - 0092
🇨ðŸ‡Bern, Switzerland
Local Institution - 0080
🇨ðŸ‡Chur, 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