A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
- Conditions
- Melanoma
- Interventions
- Biological: Nivolumab + Relatlimab Fixed Dose Combination
- Registration Number
- NCT05002569
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1190
- Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
- Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
- Complete resection must be performed within 90 days prior to randomization
- All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
- Tumor tissue must be provided for biomarker analyses
- History of ocular melanoma
- Untreated/unresected CNS metastases or leptomeningeal metastases
- Active, known, or suspected autoimmune disease
- Participants with serious or uncontrolled medical disorder
- Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
- History of myocarditis, regardless of etiology.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Nivolumab Nivolumab Monotherapy Arm A: Nivolumab Plus Relatlimab Nivolumab + Relatlimab Fixed Dose Combination Combination
- Primary Outcome Measures
Name Time Method Recurrence-Free Survival (RFS) time per Investigator assessment Approximately 52 months
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Approximately 90 months Distant Metastasis-Free Survival (DMFS) time per Investigator assessment Approximately 90 months Incidence of Serious Adverse Events (SAEs) 30 days from participant's last dose Severity of SAEs 30 days from participant's last dose Severity of IMAEs 135 days from participant's last dose Severity of drug related AEs 30 days from participant's last dose Severity of AEs 30 days from participant's last dose Incidence of Adverse Events (AEs) 30 days from participant's last dose Incidence of AEs leading to discontinuation (DC) 30 days from participant's last dose Severity of AEs leading to DC 30 days from participant's last dose Incidence of immune-mediated AEs (IMAEs) 135 days from participant's last dose Incidence of clinically significant changes in clinical laboratory values: Hematology tests 30 days from participant's last dose Incidence of clinically significant changes in clinical laboratory values: Chemistry tests 30 days from participant's last dose Progression-Free Survival 2 (PFS2) Approximately 52 months Incidence of drug related AEs 30 days from participant's last dose Incidence of deaths 30 days from participant's last dose
Trial Locations
- Locations (184)
Saint John's Cancer Institute
🇺🇸Santa Monica, California, United States
Washington University School Of Medicine
🇺🇸Miami, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
🇺🇸Tampa, Florida, United States
Dana-Farber Cancer Institute-Melanoma
🇺🇸Boston, Massachusetts, United States
Icahn School Of Medicine At Mount Sinai
🇺🇸New York, New York, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
🇺🇸Columbus, Ohio, United States
Local Institution - 0001
🇦🇷Caba, Distrito Federal, Argentina
Local Institution - 0254
🇦🇺Tiwi, Northern Territory, Australia
Local Institution - 0221
🇨🇳Hefei, Anhui, China
Local Institution - 0225
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0263
🇨🇳Tianjin, Tianjin, China
Local Institution - 0220
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0016
🇩🇰Aarhus, Midtjylland, Denmark
Helsinki University Hospital Adult ICU PPDS
🇫🇮Helsinki, Finland
Local Institution - 0123
🇮🇹Milano, Italy
Local Institution - 0115
🇮🇹Milan, Italy
Local Institution - 0268
🇮🇹Milan, Italy
Local Institution - 0119
🇮🇹Napoli, Italy
Local Institution - 0120
🇮🇹Padova, Italy
Local Institution - 0122
🇮🇹Perugia, Italy
Local Institution - 0121
🇮🇹Siena, Italy
Local Institution - 0249
🇵🇹Coimbra, Portugal
Local Institution - 0176
🇺🇸Birmingham, Alabama, United States
Local Institution - 0164
🇺🇸Springdale, Arkansas, United States
Local Institution - 0200
🇺🇸Los Angeles, California, United States
Local Institution - 0185
🇺🇸Palo Alto, California, United States
Local Institution - 0162
🇺🇸San Francisco, California, United States
Local Institution - 0138
🇺🇸Aurora, Colorado, United States
Local Institution - 0166
🇺🇸Washington, District of Columbia, United States
Local Institution - 0243
🇺🇸Miami, Florida, United States
Local Institution - 0179
🇺🇸Pensacola, Florida, United States
Local Institution - 0191
🇺🇸Atlanta, Georgia, United States
Local Institution - 0148
🇺🇸Atlanta, Georgia, United States
Local Institution - 0202
🇺🇸Chicago, Illinois, United States
Local Institution - 0177
🇺🇸Peoria, Illinois, United States
Local Institution - 0223
🇺🇸Fort Wayne, Indiana, United States
University of Iowa-Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Local Institution - 0178
🇺🇸Westwood, Kansas, United States
Local Institution - 0258
🇺🇸Ann Arbor, Michigan, United States
Local Institution
🇺🇸Grand Rapids, Michigan, United States
Local Institution - 0133
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0139
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0206
🇺🇸Morristown, New Jersey, United States
Local Institution - 0140
🇺🇸New York, New York, United States
Local Institution - 0210
🇺🇸New York, New York, United States
Local Institution - 0130
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0145
🇺🇸Durham, North Carolina, United States
Local Institution - 0141
🇺🇸Cleveland, Ohio, United States
Local Institution - 0267
🇺🇸Allentown, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0125
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0171
🇺🇸Charleston, South Carolina, United States
Local Institution - 0147
🇺🇸Germantown, Tennessee, United States
Local Institution - 0183
🇺🇸Nashville, Tennessee, United States
Local Institution - 0146
🇺🇸Austin, Texas, United States
Local Institution - 0163
🇺🇸Dallas, Texas, United States
Local Institution - 0172
🇺🇸Houston, Texas, United States
Local Institution - 0137
🇺🇸Fairfax, Virginia, United States
Local Institution - 0003
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0005
🇦🇷Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina
Local Institution - 0002
🇦🇷Ciudad de Buenos Aires, Distrito Federal, Argentina
Local Institution - 0004
🇦🇷Cordoba, Argentina
Local Institution - 0030
🇦🇺Waratah, New South Wales, Australia
Local Institution - 0252
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0032
🇦🇺Wollstonecraft, New South Wales, Australia
Local Institution - 0028
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0027
🇦🇺Southport, Queensland, Australia
Local Institution - 0250
🇦🇺Woodville, South Australia, Australia
Local Institution - 0035
🇦🇺Ballarat, Victoria, Australia
Local Institution - 0251
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0253
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0031
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0029
🇦🇺Perth, Western Australia, Australia
Local Institution - 0082
🇦🇹Graz, Steiermark, Austria
Local Institution - 0086
🇦🇹Salzburg, Austria
Local Institution - 0084
🇦🇹Vienna, Austria
Local Institution - 0110
🇧🇪Brussels, Belgium
Local Institution - 0105
🇧🇪Bruxelles, Belgium
Local Institution - 0109
🇧🇪Liège, Belgium
Local Institution - 0106
🇧🇪Wilrijk, Belgium
Local Institution - 0071
🇧🇷Salvador, Bahia, Brazil
Local Institution - 0070
🇧🇷Barretos, SAO Paulo, Brazil
Local Institution - 0058
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0155
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0175
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0197
🇨🇦Halifax, Nova Scotia, Canada
Local Institution - 0072
🇧🇷Fortaleza, Ceara, Brazil
Local Institution - 0047
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0056
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Local Institution - 0257
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0049
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0048
🇧🇷Santa Cruz do Sul, RIO Grande DO SUL, Brazil
Local Institution - 0068
🇧🇷Vitória, Espirito Santo, Brazil
Local Institution - 0158
🇨🇦Montreal, Quebec, Canada
Local Institution - 0159
🇨🇦Montréal, Quebec, Canada
Local Institution - 0160
🇨🇦Quebec City, Quebec, Canada
Local Institution - 0198
🇨🇦Sherbrooke, Quebec, Canada
Local Institution - 0013
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0006
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0014
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0259
🇨🇳Beijing, Beijing, China
Local Institution - 0261
🇨🇳Beijing, Beijing, China
Local Institution - 0214
🇨🇳Beijing, Beijing, China
Local Institution - 0241
🇨🇳Chongqing, Chongqing, China
Local Institution - 0245
🇨🇳Fuzhou City, Fujian, China
Local Institution - 0217
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0226
🇨🇳Zhengzhou Shi, Henan, China
Local Institution - 0237
🇨🇳Wuhan, Hubei, China
Local Institution - 0239
🇨🇳Wuhan, Hubei, China
Local Institution - 0234
🇨🇳Changsha Shi, Hunan, China
Local Institution - 0215
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0224
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0219
🇨🇳Changchun, Jilin, China
Local Institution - 0242
🇨🇳Shenyang, Liaoning, China
Local Institution - 0230
🇨🇳Chengdu, Sichuan, China
Local Institution - 0228
🇨🇳Urumqi, Xinjiang, China
Local Institution - 0222
🇨🇳Kunming, Yunnan, China
Local Institution - 0216
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0244
🇨🇳Taiyuan, China
Local Institution - 0156
🇨🇿Brno, Czechia
Local Institution - 0091
🇨🇿Hradec Kralove, Czechia
Local Institution - 0026
🇨🇿Ostrava, Czechia
Local Institution - 0062
🇨🇿Prague, Czechia
Local Institution - 0022
🇩🇰Aalborg, Denmark
Local Institution - 0018
🇩🇰Copenhagen, Denmark
Local Institution - 0020
🇩🇰Odense, Denmark
Local Institution - 0019
🇫🇮Tampere, Finland
Local Institution - 0015
🇫🇮Turku, Finland
Local Institution - 0040
🇫🇷Villejuif, Val-de-Marne, France
Local Institution - 0043
🇫🇷Dijon, France
Local Institution - 0044
🇫🇷Marseille, France
Local Institution - 0039
🇫🇷Nantes, France
Local Institution - 0042
🇫🇷Paris, France
Local Institution - 0041
🇫🇷Pierre-Bénite, France
Local Institution - 0046
🇫🇷Toulouse, France
Local Institution - 0092
🇩🇪Tübingen, Baden-Württemberg, Germany
Local Institution - 0079
🇩🇪Hannover, Lower Saxony, Germany
Local Institution - 0073
🇩🇪Buxtehude, Germany
Local Institution - 0077
🇩🇪Dresden, Germany
Local Institution - 0074
🇩🇪Erlangen, Germany
Local Institution - 0131
🇩🇪Essen, Germany
Local Institution - 0081
🇩🇪Gera, Germany
Local Institution - 0075
🇩🇪Heidelberg, Germany
Local Institution - 0078
🇩🇪Lübeck, Germany
Local Institution - 0083
🇩🇪Minden, Germany
Local Institution - 0076
🇩🇪Munich, Germany
Local Institution - 0080
🇩🇪Wuerzburg, Germany
Local Institution - 0114
🇬🇷Athens, Greece
Local Institution - 0113
🇬🇷Neo Faliro, Greece
Local Institution - 0112
🇬🇷Thessaloniki, Greece
Local Institution - 0199
🇮🇱Petah Tikva, HaMerkaz, Israel
Local Institution - 0118
🇮🇱Jerusalem, Yerushalayim, Israel
Local Institution - 0116
🇮🇱Afula, Israel
Local Institution - 0117
🇮🇱Ramat Gan, Israel
Local Institution - 0100
🇲🇽Benito Juarez, Distrito Federal, Mexico
Local Institution - 0021
🇲🇽Zapopan, Jalisco, Mexico
Local Institution - 0093
🇲🇽Mexico, Nuevo LEON, Mexico
Local Institution - 0098
🇲🇽Oaxaca, Mexico
Local Institution - 0009
🇳🇴Lørenskog, Akershus, Norway
Local Institution - 0023
🇳🇴Stavanger, Rogaland, Norway
Local Institution - 0017
🇳🇴Oslo, Norway
Local Institution - 0170
🇷🇴Brasov, Romania
Local Institution - 0065
🇷🇴Cluj, Romania
Local Institution - 0066
🇷🇴Craiova, Romania
Local Institution - 0064
🇷🇴Floresti/ Cluj, Romania
Local Institution - 0188
🇪🇸Badajoz, Spain
Local Institution - 0201
🇪🇸Barcelona, Spain
Local Institution - 0153
🇪🇸Granada, Spain
Local Institution - 0150
🇪🇸Madrid, Spain
Local Institution - 0151
🇪🇸San Sebastian, Spain
Local Institution - 0152
🇪🇸València, Spain
Local Institution - 0010
🇸🇪Gothenburg, Sweden
Local Institution - 0011
🇸🇪Lund, Sweden
Local Institution - 0012
🇸🇪Solna, Sweden
Local Institution - 0085
🇨🇭Basel, Switzerland
Local Institution - 0087
🇨🇭Chur, Switzerland
Local Institution - 0090
🇨🇭Zürich, Switzerland
Local Institution - 0101
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0102
🇬🇧Bristol, United Kingdom
Local Institution - 0187
🇬🇧Glasgow, United Kingdom
Local Institution - 0154
🇬🇧Newcastle upon Tyne, United Kingdom
Local Institution - 0232
🇬🇧Oxford, United Kingdom
Local Institution - 0127
🇬🇧Southampton, United Kingdom