A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
- Conditions
- Melanoma
- Interventions
- Biological: RelatlimabBiological: Nivolumab
- Registration Number
- NCT03470922
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 714
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Relatlimab + Nivolumab Nivolumab Combination Arm A: Relatlimab + Nivolumab Relatlimab Combination Arm B: Nivolumab Nivolumab Monotherapy
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) 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).
Overall Survival (OS) 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").
Trial Locations
- Locations (127)
Local Institution - 0012
🇺🇸Washington, District of Columbia, United States
Local Institution - 0117
🇺🇸Orlando, Florida, United States
Local Institution - 0043
🇦🇺Waratah, New South Wales, Australia
Local Institution - 0003
🇦🇷Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0059
🇧🇷Rio De Janiro, Brazil
Local Institution - 0036
🇦🇹Graz, Austria
Local Institution - 0024
🇪🇸Barcelona, Spain
Local Institution - 0023
🇪🇸A Coruña, Spain
Local Institution - 0105
🇩🇰Aarhus N, Denmark
Local Institution - 0081
🇫🇷Marseille, France
Local Institution - 0082
🇫🇷Poitiers, France
Local Institution - 0026
🇪🇸Madrid, Spain
Local Institution - 0078
🇫🇷Pierre-Benite, France
Local Institution - 0025
🇪🇸Barcelona, Spain
Local Institution - 0030
🇩🇪Erfurt, Germany
Local Institution - 0072
🇩🇪Mannheim, Germany
Local Institution - 0021
🇪🇸San Sabastian Gipuzkoa, Spain
Local Institution - 0052
🇬🇧Bristol, Avon, United Kingdom
Local Institution - 0098
🇸🇪Goteborg, Sweden
Local Institution - 0118
🇸🇪Solna, Sweden
Local Institution - 0056
🇬🇧Swansea, Glamorgan, United Kingdom
Local Institution - 0068
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0135
🇦🇷Buenos Aires, Distrito Federal, Argentina
Local Institution - 0005
🇦🇷Buenos Aires, Argentina
Local Institution - 0063
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 0060
🇧🇷Sao Paulo, Brazil
Local Institution - 0085
🇫🇷Lille, France
Local Institution - 0027
🇩🇪Essen, Germany
Local Institution - 0123
🇨🇦Montreal, Quebec, Canada
Local Institution - 0096
🇨🇴Medellín, Antioquia, Colombia
Local Institution - 0084
🇫🇷Rennes, Ille-et-Vilaine, France
Local Institution - 0131
🇩🇪Tübingen, Baden-Württemberg, Germany
Local Institution - 0065
🇬🇷Thessaloniki, Greece
Local Institution - 0032
🇩🇪Buxtehude, Germany
Local Institution - 0132
🇩🇪Heidelberg, Germany
Local Institution - 0029
🇩🇪Köln, Germany
Local Institution - 0108
🇮🇹Milano, Italy
Local Institution - 0031
🇩🇪Wuerzburg, Germany
Local Institution - 0088
🇮🇱Jerusalem, Israel
Local Institution - 0129
🇲🇽Veracruz, Mexico
Local Institution - 0086
🇮🇱Haifa, Israel
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Istituto Oncologico Veneto IOV
🇮🇹Padova, Italy
Local Institution - 0092
🇲🇽Merida, Yucatan, Mexico
Local Institution - 0121
🇳🇴Oslo, Norway
Local Institution - 0091
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0127
🇷🇺Krasnoyarsk, Russian Federation
Local Institution - 0039
🇵🇱Warszawa, Poland
Local Institution - 0070
🇷🇴Cluj-Napoca, Cluj, Romania
Local Institution - 0069
🇷🇴Iasi, Romania
Coastal Integrative Cancer Care
🇺🇸San Luis Obispo, California, United States
Local Institution - 0058
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0073
🇧🇷Santa Cruz do Sul, RIO Grande DO SUL, Brazil
Local Institution - 0057
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0061
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0013
🇺🇸Jacksonville, Florida, United States
Local Institution - 0015
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0018
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0037
🇦🇹Salzburg, Austria
Local Institution - 0047
🇧🇪Brussels, Belgium
Local Institution - 0035
🇦🇹Wien, Austria
Local Institution - 0049
🇧🇪Bruxelles, Belgium
Local Institution - 0048
🇧🇪Gent, Belgium
Local Institution - 0075
🇨🇦Montreal, Quebec, Canada
Local Institution - 0001
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0119
🇫🇮Tampere, Finland
Local Institution - 0104
🇩🇰Odense, Denmark
Local Institution - 0095
🇨🇴Bogota, Colombia
Local Institution - 0079
🇫🇷Amiens, Somme, France
Local Institution - 0034
🇩🇪Muenchen, Germany
Local Institution - 0111
🇮🇹Torino, Piemonte, Italy
Local Institution - 0094
🇲🇽Zapopan, Jalisco, Mexico
Local Institution - 0089
🇳🇿Tauranga, New Zealand
Local Institution - 0125
🇳🇿Hamilton, New Zealand
Local Institution - 0051
🇬🇧London, Greater London, United Kingdom
Local Institution - 0103
🇩🇰Herlev, Denmark
Local Institution - 0099
🇸🇪Lund, Sweden
Local Institution - 0122
🇸🇪Uppsala, Sweden
Local Institution - 0020
🇺🇸Los Angeles, California, United States
Local Institution - 0116
🇺🇸Santa Barbara, California, 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 - 0120
🇺🇸Baltimore, Maryland, United States
Local Institution - 0134
🇺🇸Boston, Massachusetts, United States
Local Institution - 0009
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0011
🇺🇸Rochester, Minnesota, 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 - 0054
🇬🇧Glasgow, Dumfries & Galloway, United Kingdom
Local Institution - 0126
🇬🇧Inverness, Inverness-shire, United Kingdom
Local Institution - 0042
🇦🇺North Sydney, New South Wales, Australia
Local Institution - 0044
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0022
🇪🇸Sevilla, Spain
Local Institution - 0007
🇺🇸Tampa, Florida, United States
Local Institution - 0010
🇺🇸Tucson, Arizona, United States
Local Institution - 0083
🇫🇷Paris, France
Local Institution - 0002
🇦🇷Capital Federal, Distrito Federal, Argentina
Local Institution - 0004
🇦🇷Buenos Aires, Argentina
Local Institution - 0077
🇺🇸Baltimore, Maryland, United States
Local Institution - 0014
🇺🇸Boston, Massachusetts, United States
Local Institution - 0128
🇨🇦Toronto, Ontario, Canada
Local Institution - 0062
🇧🇷Sao Paulo, Brazil
Local Institution - 0102
🇫🇮Oulu, Finland
Local Institution - 0101
🇫🇮Turku, Finland
Local Institution - 0080
🇫🇷Bordeaux Cedex, France
Local Institution - 0124
🇨🇦Halifax, Nova Scotia, Canada
Local Institution - 0041
🇦🇺Greenslopes, Queensland, Australia
Local Institution - 0045
🇦🇺Southport, Queensland, Australia
Local Institution - 0133
🇦🇺Bedford Park, South Australia, Australia
Local Institution - 0100
🇫🇮Helsinki, Uusimaa, Finland
Local Institution - 0064
🇬🇷Athens, Greece
Local Institution - 0090
🇳🇿Dunedin, New Zealand
Local Institution - 0040
🇵🇱Poznan, Wielkopolskie, Poland
Local Institution - 0112
🇷🇺Moscow, Russian Federation
Local Institution - 0071
🇩🇪Quedlinburg, Sachsen-Anhalt, Germany
Local Institution - 0033
🇩🇪Hannover, Germany
Local Institution - 0074
🇩🇪Homburg / Saar, Germany
Local Institution - 0028
🇩🇪Lubeck, Germany
Local Institution - 0087
🇮🇱Ramat-gan, Israel
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Napoli, Italy
AOUS - Policlinico S.Maria Alle Scotte
🇮🇹Siena, Italy
Local Institution - 0066
🇷🇴Bucharest, Romania
Local Institution - 0067
🇷🇴Craiova, Romania
Local Institution - 0113
🇷🇺Krasnodar, Russian Federation
Local Institution - 0093
🇲🇽Cancún, Quintana Roo, Mexico