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A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
Study Purpose
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.
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 |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- - 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.
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. |
NCT03470922 |
|
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 2/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, Colombia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Sweden, 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: Relatlimab + Nivolumab
Combination
Experimental: Arm B: Nivolumab
Monotherapy
Interventions
Biological: - Relatlimab
Specified dose on specified day
Biological: - Nivolumab
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 - 0010
Tucson, Arizona, 85724-5024
Status
Address
Local Institution - 0020
Los Angeles, California, 90095
Status
Address
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401
Status
Address
Local Institution - 0116
Santa Barbara, California, 93105
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Address
Local Institution - 0012
Washington, District of Columbia, 20007
Status
Address
Local Institution - 0013
Jacksonville, Florida, 32224
Status
Address
Local Institution - 0117
Orlando, Florida, 32806
Status
Address
Local Institution - 0007
Tampa, Florida, 33612
Status
Address
Local Institution - 0038
Atlanta, Georgia, 30342
Status
Address
Local Institution - 0016
Chicago, Illinois, 60611
Status
Address
Local Institution - 0114
Fort Wayne, Indiana, 46804
Status
Address
Local Institution - 0077
Baltimore, Maryland, 21237
Status
Address
Local Institution - 0120
Baltimore, Maryland, 21287
Status
Address
Local Institution - 0014
Boston, Massachusetts, 02215
Status
Address
Local Institution - 0134
Boston, Massachusetts, 02215
Status
Address
Local Institution - 0015
Ann Arbor, Michigan, 48109
Status
Address
Local Institution - 0009
Minneapolis, Minnesota, 55407
Status
Address
Local Institution - 0011
Rochester, Minnesota, 55905
Status
Address
Local Institution - 0018
Charlotte, North Carolina, 28204
Status
Address
Local Institution - 0019
Allentown, Pennsylvania, 18103
Status
Address
Local Institution - 0076
Dallas, Texas, 75246
Status
Address
Local Institution - 0008
Houston, Texas, 77030
International Sites
Status
Address
Local Institution - 0135
Buenos Aires, Distrito Federal, 1121
Status
Address
Local Institution - 0002
Capital Federal, Distrito Federal, C1280AEB
Status
Address
Local Institution - 0004
Buenos Aires, , 1199
Status
Address
Local Institution - 0005
Buenos Aires, , 4102-4200
Status
Address
Local Institution - 0003
Ciudad Autónoma De Buenos Aires, , 1426
Status
Address
Local Institution - 0042
North Sydney, New South Wales, 2060
Status
Address
Local Institution - 0043
Waratah, New South Wales, 2298
Status
Address
Local Institution - 0041
Greenslopes, Queensland, 4120
Status
Address
Local Institution - 0045
Southport, Queensland, 4215
Status
Address
Local Institution - 0133
Bedford Park, South Australia, 5042
Status
Address
Local Institution - 0044
Murdoch, Western Australia, 6150
Status
Address
Local Institution - 0036
Graz, Steiermark, 8036
Status
Address
Local Institution - 0037
Salzburg, , 5020
Status
Address
Local Institution - 0035
Wien, , 1090
Status
Address
Local Institution - 0047
Brussels, , 1090
Status
Address
Local Institution - 0049
Bruxelles, , 1200
Status
Address
Local Institution - 0048
Gent, , 9000
Status
Address
Local Institution - 0058
Belo Horizonte, Minas Gerais, 30130-090
Status
Address
Local Institution - 0057
Porto Alegre, Rio Grande Do Sul, 90035-903
Status
Address
Local Institution - 0061
Porto Alegre, RIO Grande DO SUL, 91350-200
Status
Address
Local Institution - 0073
Santa Cruz do Sul, RIO Grande DO SUL, 96810-110
Status
Address
Local Institution - 0063
São Paulo, SAO Paulo, 05651-901
Status
Address
Local Institution - 0059
Rio De Janiro, , 20220-410
Status
Address
Local Institution - 0060
Sao Paulo, , 01246-000
Status
Address
Local Institution - 0062
Sao Paulo, , 01509-010
Status
Address
Local Institution - 0124
Halifax, Nova Scotia, B3H 2Y9
Status
Address
Local Institution - 0068
Ottawa, Ontario, K1H 8L6
Status
Address
Local Institution - 0128
Toronto, Ontario, M5G 2M9
Status
Address
Local Institution - 0123
Montreal, Quebec, H3T 1E2
Status
Address
Local Institution - 0075
Montreal, Quebec, H4A 3J1
Status
Address
Local Institution - 0001
Santiago, Metropolitana,
Status
Address
Local Institution - 0096
Medellín, Antioquia, 050030
Status
Address
Local Institution - 0095
Bogota, , 110321
Status
Address
Local Institution - 0105
Aarhus N, Midtjylland, 8200
Status
Address
Local Institution - 0103
Herlev, , 2730
Status
Address
Local Institution - 0104
Odense, , 5000
Status
Address
Local Institution - 0100
Helsinki, Uusimaa, 00290
Status
Address
Local Institution - 0102
Oulu, , 90220
Status
Address
Local Institution - 0119
Tampere, , 33521
Status
Address
Local Institution - 0101
Turku, , 20520
Status
Address
Local Institution - 0084
Rennes, Ille-et-Vilaine, 35042
Status
Address
Local Institution - 0079
Amiens, Somme, 80000
Status
Address
Local Institution - 0080
Bordeaux Cedex, , 33075
Status
Address
Local Institution - 0085
Lille, , 59000
Status
Address
Local Institution - 0081
Marseille, , 13011
Status
Address
Local Institution - 0083
Paris, , 75010
Status
Address
Local Institution - 0078
Pierre-Benite, , 69310
Status
Address
Local Institution - 0082
Poitiers, , 86000
Status
Address
Local Institution - 0132
Heidelberg, Baden-Württemberg, 69120
Status
Address
Local Institution - 0131
Tübingen, Baden-Württemberg, 72076
Status
Address
Local Institution - 0071
Quedlinburg, Sachsen-Anhalt, 06484
Status
Address
Local Institution - 0032
Buxtehude, , 21614
Status
Address
Local Institution - 0030
Erfurt, , 99089
Status
Address
Local Institution - 0027
Essen, , 45147
Status
Address
Local Institution - 0033
Hannover, , 30625
Status
Address
Local Institution - 0074
Homburg / Saar, , 66421
Status
Address
Local Institution - 0029
Köln, , 50937
Status
Address
Local Institution - 0028
Lubeck, , 23538
Status
Address
Local Institution - 0072
Mannheim, , 68167
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Address
Local Institution - 0034
Muenchen, , 81675
Status
Address
Local Institution - 0031
Wuerzburg, , 97080
Status
Address
Local Institution - 0064
Athens, , 11526
Status
Address
Local Institution - 0065
Thessaloniki, , 54622
Status
Address
Local Institution - 0086
Haifa, , 3109601
Status
Address
Local Institution - 0088
Jerusalem, , 91120
Status
Address
Local Institution - 0087
Ramat-gan, , 52621
Status
Address
Local Institution - 0111
Torino, Piemonte, 10126
Status
Address
Local Institution - 0109
Bergamo, , 24127
Status
Address
Local Institution - 0108
Milano, , 20133
Status
Address
Local Institution - 0106
Napoli, , 80131
Status
Address
Local Institution - 0110
Padova, , 35128
Status
Address
Local Institution - 0107
Siena, , 53100
Status
Address
Local Institution - 0094
Zapopan, Jalisco, 45070
Status
Address
Local Institution - 0091
Monterrey, Nuevo LEON, 64060
Status
Address
Local Institution - 0093
Cancún, Quintana Roo, 77500
Status
Address
Local Institution - 0092
Mérida, Yucatán, 97130
Status
Address
Local Institution - 0129
Veracruz, , 91900
Status
Address
Local Institution - 0090
Dunedin, , 9012
Status
Address
Local Institution - 0125
Hamilton, , 3240
Status
Address
Local Institution - 0089
Tauranga, , 3112
Status
Address
Local Institution - 0121
Oslo, , 0310
Status
Address
Local Institution - 0040
Poznan, , 60-780
Status
Address
Local Institution - 0039
Warszawa, , 02-781
Status
Address
Local Institution - 0070
Cluj-Napoca, Cluj, 400015
Status
Address
Local Institution - 0066
Bucharest, , 022328
Status
Address
Local Institution - 0067
Craiova, , 200542
Status
Address
Local Institution - 0069
Iasi, , 700483
Status
Address
Local Institution - 0113
Krasnodar, , 350040
Status
Address
Local Institution - 0127
Krasnoyarsk, , 660133
Status
Address
Local Institution - 0112
Moscow, , 115478
Status
Address
Local Institution - 0023
A Coruña, , 15006
Status
Address
Local Institution - 0024
Barcelona, , 08035
Status
Address
Local Institution - 0025
Barcelona, , 08036
Status
Address
Local Institution - 0026
Madrid, , 28034
Status
Address
Local Institution - 0021
San Sabastian Gipuzkoa, , 20014
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Address
Local Institution - 0022
Sevilla, , 41009
Status
Address
Local Institution - 0098
Goteborg, , 413 45
Status
Address
Local Institution - 0099
Lund, , 221 85
Status
Address
Local Institution - 0118
Solna, , 171 64
Status
Address
Local Institution - 0122
Uppsala, , 751 85
Status
Address
Local Institution - 0052
Bristol, Avon, BS2 8ED
Status
Address
Local Institution - 0054
Glasgow, Dumfries & Galloway, G12 0YN
Status
Address
Local Institution - 0056
Swansea, Glamorgan, SA2 8QA
Status
Address
Local Institution - 0051
London, Greater London, SE1 9RT
Status
Address
Local Institution - 0126
Inverness, Inverness-shire, IV2 3UJ
