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A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Study Purpose
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.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years and Over |
| Gender | All |
Inclusion Criteria:
- - 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.
- - 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.
Exclusion Criteria:
- - 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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05002569 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bristol-Myers Squibb |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
| Principal Investigator Affiliation | Bristol-Myers Squibb |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Norway, Portugal, Romania, Spain, Sweden, Switzerland, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma |
| Study Website: | View Trial Website |
Arms
Experimental: Arm A: Nivolumab Plus Relatlimab
Combination
Experimental: Arm B: Nivolumab
Monotherapy
Interventions
Biological: - Nivolumab
Specified dose on specified days
Biological: - Nivolumab + Relatlimab Fixed Dose Combination
Specified dose on specified days
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Local Institution - 0176
Birmingham, Alabama, 35249
Status
Address
Local Institution - 0164
Springdale, Arkansas, 72762
Status
Address
Local Institution - 0200
Los Angeles, California, 90025
Status
Address
Local Institution - 0185
Palo Alto, California, 94304
Status
Address
Local Institution - 0162
San Francisco, California, 94115
Status
Address
Saint John's Cancer Institute
Santa Monica, California, 90404
Status
Address
Local Institution - 0138
Aurora, Colorado, 80045
Status
Address
Local Institution - 0166
Washington, District of Columbia, 20007
Status
Address
Local Institution - 0243
Miami, Florida, 33136
Status
Address
Washington University School Of Medicine
Miami, Florida, 33136
Status
Address
Local Institution - 0179
Pensacola, Florida, 32504
Status
Address
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612
Status
Address
Local Institution - 0191
Atlanta, Georgia, 30322
Status
Address
Local Institution - 0148
Atlanta, Georgia, 30342
Status
Address
Local Institution - 0202
Chicago, Illinois, 60611
Status
Address
Local Institution - 0177
Peoria, Illinois, 61615
Status
Address
Local Institution - 0223
Fort Wayne, Indiana, 46804
Status
Address
University of Iowa-Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Status
Address
Local Institution - 0178
Westwood, Kansas, 66205
Status
Address
Dana-Farber Cancer Institute-Melanoma
Boston, Massachusetts, 02215
Status
Address
Local Institution - 0258
Ann Arbor, Michigan, 48109
Status
Address
Local Institution
Grand Rapids, Michigan, 49503
Status
Address
Local Institution - 0133
Minneapolis, Minnesota, 55407
Status
Address
Local Institution - 0139
Hackensack, New Jersey, 07601
Status
Address
Local Institution - 0206
Morristown, New Jersey, 07960
Status
Address
Local Institution - 0140
New York, New York, 10016
Status
Address
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029
Status
Address
Local Institution - 0210
New York, New York, 10065
Status
Address
Local Institution - 0130
Charlotte, North Carolina, 28204
Status
Address
Local Institution - 0145
Durham, North Carolina, 27710
Status
Address
MetroHealth Medical Center
Cleveland, Ohio, 44109
Status
Address
Local Institution - 0141
Cleveland, Ohio, 44195
Status
Address
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio, 43210
Status
Address
Local Institution - 0267
Allentown, Pennsylvania, 18103
Status
Address
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Status
Address
Local Institution - 0125
Pittsburgh, Pennsylvania, 15232
Status
Address
Local Institution - 0171
Charleston, South Carolina, 29425
Status
Address
Local Institution - 0147
Germantown, Tennessee, 38138
Status
Address
Local Institution - 0183
Nashville, Tennessee, 37232
Status
Address
Local Institution - 0146
Austin, Texas, 78731
Status
Address
Local Institution - 0163
Dallas, Texas, 75246
Status
Address
Local Institution - 0172
Houston, Texas, 77030
Status
Address
Local Institution - 0137
Fairfax, Virginia, 22031
International Sites
Status
Address
Local Institution - 0003
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
Status
Address
Local Institution - 0001
Caba, Distrito Federal, C1430
Status
Address
Local Institution - 0005
Ciudad Autónoma de Buenos Aires, Distrito Federal, 1426
Status
Address
Local Institution - 0002
Ciudad de Buenos Aires, Distrito Federal, C1121ABE
Status
Address
Local Institution - 0004
Cordoba, , X5002HWE
Status
Address
Local Institution - 0030
Waratah, New South Wales, 2298
Status
Address
Local Institution - 0252
Westmead, New South Wales, 2145
Status
Address
Local Institution - 0032
Wollstonecraft, New South Wales, 2065
Status
Address
Local Institution - 0254
Tiwi, Northern Territory, 0810
Status
Address
Local Institution - 0028
Brisbane, Queensland, 4102
Status
Address
Local Institution - 0027
Southport, Queensland, 4215
Status
Address
Local Institution - 0250
Woodville, South Australia, 5011
Status
Address
Local Institution - 0035
Ballarat, Victoria, 3350
Status
Address
Local Institution - 0253
Heidelberg, Victoria, 3084
Status
Address
Local Institution - 0031
Melbourne, Victoria, 3000
Status
Address
Local Institution - 0251
Murdoch, Western Australia, 6150
Status
Address
Local Institution - 0029
Perth, Western Australia, 6009
Status
Address
Local Institution - 0082
Graz, Steiermark, 8036
Status
Address
Local Institution - 0086
Salzburg, , 5020
Status
Address
Local Institution - 0084
Vienna, , 1090
Status
Address
Local Institution - 0110
Brussels, , 1090
Status
Address
Local Institution - 0105
Bruxelles, , 1200
Status
Address
Local Institution - 0109
Liège, , 4000
Status
Address
Local Institution - 0106
Wilrijk, , 2610
Status
Address
Local Institution - 0071
Salvador, Bahia, 40170-070
Status
Address
Local Institution - 0072
Fortaleza, Ceara, 60135237
Status
Address
Local Institution - 0068
Vitória, Espirito Santo, 29055450
Status
Address
Local Institution - 0047
Belo Horizonte, Minas Gerais, 30130-090
Status
Address
Local Institution - 0056
Ijui, Rio Grande Do Sul, 98700-000
Status
Address
Local Institution - 0257
Porto Alegre, RIO Grande DO SUL, 90035-903
Status
Address
Local Institution - 0049
Porto Alegre, RIO Grande DO SUL, 91350-200
Status
Address
Local Institution - 0048
Santa Cruz do Sul, RIO Grande DO SUL, 96830-180
Status
Address
Local Institution - 0070
Barretos, SAO Paulo, 14784400
Status
Address
Local Institution - 0058
Rio de Janeiro, , 20220-410
Status
Address
Local Institution - 0155
Edmonton, Alberta, T6X 1E8
Status
Address
Local Institution - 0175
Vancouver, British Columbia, V5Z 4E6
Status
Address
Local Institution - 0197
Halifax, Nova Scotia, B3H 2Y9
Status
Address
Local Institution - 0158
Montreal, Quebec, H3T 1E2
Status
Address
Local Institution - 0159
Montréal, Quebec, H2X 1P1
Status
Address
Local Institution - 0160
Quebec City, Quebec, G1J 1Z4
Status
Address
Local Institution - 0198
Sherbrooke, Quebec, J1H 5N4
Status
Address
Local Institution - 0013
Santiago, Metropolitana, 7510032
Status
Address
Local Institution - 0006
Santiago, Metropolitana, 8420383
Status
Address
Local Institution - 0014
Santiago, Metropolitana,
Status
Address
Local Institution - 0221
Hefei, Anhui, 230022
Status
Address
Local Institution - 0259
Beijing, Beijing, 100034
Status
Address
Local Institution - 0261
Beijing, Beijing, 100035
Status
Address
Local Institution - 0214
Beijing, Beijing, 100142
Status
Address
Local Institution - 0241
Chongqing, Chongqing, 400030
Status
Address
Local Institution - 0245
Fuzhou City, Fujian, 350014
Status
Address
Local Institution - 0217
Guangzhou, Guangdong, 510060
Status
Address
Local Institution - 0226
Zhengzhou Shi, Henan, 450001
Status
Address
Local Institution - 0237
Wuhan, Hubei, 430022
Status
Address
Local Institution - 0239
Wuhan, Hubei, 430030
Status
Address
Local Institution - 0234
Changsha Shi, Hunan, 410013
Status
Address
Local Institution - 0215
Nanjing, Jiangsu, 210000
Status
Address
Local Institution - 0225
Nanjing, Jiangsu, 210029
Status
Address
Local Institution - 0224
Nanchang, Jiangxi, 330006
Status
Address
Local Institution - 0219
Changchun, Jilin, 130021
Status
Address
Local Institution - 0242
Shenyang, Liaoning, 110001
Status
Address
Local Institution - 0230
Chengdu, Sichuan, 610041
Status
Address
Local Institution - 0263
Tianjin, Tianjin, 300060
Status
Address
Local Institution - 0228
Urumqi, Xinjiang, 830000
Status
Address
Local Institution - 0222
Kunming, Yunnan, 650106
Status
Address
Local Institution - 0220
Hangzhou, Zhejiang, 310016
Status
Address
Local Institution - 0216
Hangzhou, Zhejiang, 310022
Status
Address
Local Institution - 0244
Taiyuan, , 030032
Status
Address
Local Institution - 0156
Brno, , 65653
Status
Address
Local Institution - 0091
Hradec Kralove, , 50005
Status
Address
Local Institution - 0026
Ostrava, , 708 52
Status
Address
Local Institution - 0062
Prague, , 12808
Status
Address
Local Institution - 0016
Aarhus, Midtjylland, 8200
Status
Address
Local Institution - 0022
Aalborg, , 9100
Status
Address
Local Institution - 0018
Copenhagen, , 2730
Status
Address
Local Institution - 0020
Odense, , 5000
Status
Address
Helsinki University Hospital Adult ICU PPDS
Helsinki, , 00290
Status
Address
Local Institution - 0019
Tampere, , 33520
Status
Address
Local Institution - 0015
Turku, , 20521
Status
Address
Local Institution - 0040
Villejuif, Val-de-Marne, 94800
Status
Address
Local Institution - 0043
Dijon, , 21000
Status
Address
Local Institution - 0044
Marseille, , 13385
Status
Address
Local Institution - 0039
Nantes, , 44093
Status
Address
Local Institution - 0042
Paris, , 75010
Status
Address
Local Institution - 0041
Pierre-Bénite, , 69310
Status
Address
Local Institution - 0046
Toulouse, , 31100
Status
Address
Local Institution - 0092
Tübingen, Baden-Württemberg, 72076
Status
Address
Local Institution - 0079
Hannover, Lower Saxony, 30625
Status
Address
Local Institution - 0073
Buxtehude, , 21614
Status
Address
Local Institution - 0077
Dresden, , 01307
Status
Address
Local Institution - 0074
Erlangen, , 91054
Status
Address
Local Institution - 0131
Essen, , 45147
Status
Address
Local Institution - 0081
Gera, , 07548
Status
Address
Local Institution - 0075
Heidelberg, , D-69120
Status
Address
Local Institution - 0078
Lübeck, , 23538
Status
Address
Local Institution - 0083
Minden, , 32429
Status
Address
Local Institution - 0076
Munich, , 80337
Status
Address
Local Institution - 0080
Wuerzburg, , 97080
Status
Address
Local Institution - 0114
Athens, , 11527
Status
Address
Local Institution - 0113
Neo Faliro, , 185 47
Status
Address
Local Institution - 0112
Thessaloniki, , 540 07
Status
Address
Local Institution - 0199
Petah Tikva, HaMerkaz, 4941492
Status
Address
Local Institution - 0118
Jerusalem, Yerushalayim, 9112001
Status
Address
Local Institution - 0116
Afula, , 1834111
Status
Address
Local Institution - 0117
Ramat Gan, , 5262100
Status
Address
Local Institution - 0123
Milano, , 20141
Status
Address
Local Institution - 0115
Milan, , 20133
Status
Address
Local Institution - 0268
Milan, , 20133
Status
Address
Local Institution - 0119
Napoli, , 80131
Status
Address
Local Institution - 0120
Padova, , 35128
Status
Address
Local Institution - 0122
Perugia, , 06132
Status
Address
Local Institution - 0121
Siena, , 53100
Status
Address
Local Institution - 0100
Benito Juarez, Distrito Federal, 03240
Status
Address
Local Institution - 0021
Zapopan, Jalisco, 45070
Status
Address
Local Institution - 0093
Mexico, Nuevo LEON, 64320
Status
Address
Local Institution - 0098
Oaxaca, , 68020
Status
Address
Local Institution - 0009
Lørenskog, Akershus, 1478
Status
Address
Local Institution - 0023
Stavanger, Rogaland, 4011
Status
Address
Local Institution - 0017
Oslo, , 0310
Status
Address
Local Institution - 0249
Coimbra, , 3000-075
Status
Address
Local Institution - 0170
Brasov, , 500283
Status
Address
Local Institution - 0065
Cluj, , 400015
Status
Address
Local Institution - 0066
Craiova, , 200542
Status
Address
Local Institution - 0064
Floresti/ Cluj, , 407280
Status
Address
Local Institution - 0188
Badajoz, , 06071
Status
Address
Local Institution - 0201
Barcelona, , 08035
Status
Address
Local Institution - 0153
Granada, , 18012
Status
Address
Local Institution - 0150
Madrid, , 28009
Status
Address
Local Institution - 0151
San Sebastian, , 20014
Status
Address
Local Institution - 0152
València, , 46026
Status
Address
Local Institution - 0010
Gothenburg, , 41345
Status
Address
Local Institution - 0011
Lund, , 221 85
Status
Address
Local Institution - 0012
Solna, , 171 64
Status
Address
Local Institution - 0085
Basel, , 4031
Status
Address
Local Institution - 0087
Chur, , 7000
Status
Address
Local Institution - 0090
Zürich, , 8091
Status
Address
Local Institution - 0101
Nottingham, Nottinghamshire, NG5 1PB
Status
Address
Local Institution - 0102
Bristol, , BS2 8ED
Status
Address
Local Institution - 0187
Glasgow, , G12 0YN
Status
Address
Local Institution - 0154
Newcastle upon Tyne, , NE7 7DN
Status
Address
Local Institution - 0232
Oxford, , OX3 7LE
Status
Address
Local Institution - 0127
Southampton, , SO16 0YD
