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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 monotherapy 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, Russia, 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 5318313, Arizona 5551752, 85724-5024
Status
Address
Local Institution - 0020
Los Angeles 5368361, California 5332921, 90095
Status
Address
Coastal Integrative Cancer Care
San Luis Obispo 5392323, California 5332921, 93401
Status
Address
Local Institution - 0116
Santa Barbara 5392952, California 5332921, 93105
Status
Address
Local Institution - 0012
Washington D.C. 4140963, District of Columbia 4138106, 20007
Status
Address
Local Institution - 0013
Jacksonville 4160021, Florida 4155751, 32224
Status
Address
Local Institution - 0117
Orlando 4167147, Florida 4155751, 32806
Status
Address
Local Institution - 0007
Tampa 4174757, Florida 4155751, 33612
Status
Address
Local Institution - 0038
Atlanta 4180439, Georgia 4197000, 30342
Status
Address
Local Institution - 0016
Chicago 4887398, Illinois 4896861, 60611
Status
Address
Local Institution - 0114
Fort Wayne 4920423, Indiana 4921868, 46804
Status
Address
Local Institution - 0077
Baltimore 4347778, Maryland 4361885, 21237
Status
Address
Local Institution - 0120
Baltimore 4347778, Maryland 4361885, 21287
Status
Address
Local Institution - 0014
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
Local Institution - 0134
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
Local Institution - 0015
Ann Arbor 4984247, Michigan 5001836, 48109
Status
Address
Local Institution - 0009
Minneapolis 5037649, Minnesota 5037779, 55407
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Address
Local Institution - 0011
Rochester 5043473, Minnesota 5037779, 55905
Status
Address
Local Institution - 0018
Charlotte 4460243, North Carolina 4482348, 28204
Status
Address
Local Institution - 0019
Allentown 5178127, Pennsylvania 6254927, 18103
Status
Address
Local Institution - 0076
Dallas 4684888, Texas 4736286, 75246
Status
Address
Local Institution - 0008
Houston 4699066, Texas 4736286, 77030
International Sites
Status
Address
Local Institution - 0135
Buenos Aires 3435910, Distrito Federal, 1121
Status
Address
Local Institution - 0002
Capital Federal, Distrito Federal, C1280AEB
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Local Institution - 0004
Buenos Aires 3435910, , 1199
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Address
Local Institution - 0003
Buenos Aires 3435910, , 1426
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Local Institution - 0005
Buenos Aires 3435910, , 4102-4200
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Local Institution - 0042
North Sydney 2154855, New South Wales 2155400, 2060
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Address
Local Institution - 0043
Waratah 10103871, New South Wales 2155400, 2298
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Local Institution - 0041
Greenslopes 9957342, Queensland 2152274, 4120
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Local Institution - 0045
Southport 2148928, Queensland 2152274, 4215
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Local Institution - 0133
Bedford Park 2076918, South Australia 2061327, 5042
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Local Institution - 0044
Murdoch 8349091, Western Australia 2058645, 6150
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Local Institution - 0036
Graz 2778067, Styria 2764581, 8036
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Local Institution - 0037
Salzburg 2766824, , 5020
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Local Institution - 0035
Vienna 2761369, , 1090
Status
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Local Institution - 0047
Brussels 2800866, , 1090
Status
Address
Local Institution - 0049
Brussels 2800866, , 1200
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Address
Local Institution - 0048
Ghent 2797656, , 9000
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Local Institution - 0058
Belo Horizonte 3470127, Minas Gerais 3457153, 30130-090
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Local Institution - 0057
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90035-903
Status
Address
Local Institution - 0061
Porto Alegre 3452925, Rio Grande do Sul 3451133, 91350-200
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Local Institution - 0073
Santa Cruz do Sul 3450269, Rio Grande do Sul 3451133, 96810-110
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Address
Local Institution - 0063
São Paulo 3448439, São Paulo 3448433, 05651-901
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Local Institution - 0059
Rio de Janiro, , 20220-410
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Local Institution - 0060
São Paulo 3448439, , 01246-000
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Local Institution - 0062
São Paulo 3448439, , 01509-010
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Address
Local Institution - 0124
Halifax 6324729, Nova Scotia 6091530, B3H 2Y9
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Local Institution - 0068
Ottawa 6094817, Ontario 6093943, K1H 8L6
Status
Address
Local Institution - 0128
Toronto 6167865, Ontario 6093943, M5G 2M9
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Local Institution - 0123
Montreal 6077243, Quebec 6115047, H3T 1E2
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Address
Local Institution - 0075
Montreal 6077243, Quebec 6115047, H4A 3J1
Status
Address
Local Institution - 0001
Santiago 3871336, Santiago Metropolitan 3873544,
Status
Address
Local Institution - 0096
Medellín 3674962, Antioquia 3689815, 050030
Status
Address
Local Institution - 0095
Bogotá 3688689, , 110321
Status
Address
Local Institution - 0105
Aarhus N 11746890, Central Jutland 6418539, 8200
Status
Address
Local Institution - 0103
Herlev 2620431, , 2730
Status
Address
Local Institution - 0104
Odense 2615876, , 5000
Status
Address
Local Institution - 0100
Helsinki 658225, Uusimaa 830709, 00290
Status
Address
Local Institution - 0102
Oulu 643492, , 90220
Status
Address
Local Institution - 0119
Tampere 634963, , 33521
Status
Address
Local Institution - 0101
Turku 633679, , 20520
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Address
Local Institution - 0084
Rennes 2983990, Ille-et-Vilaine, 35042
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Address
Local Institution - 0079
Amiens 3037854, Somme, 80000
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Local Institution - 0080
Bordeaux 3031582, , 33075
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Local Institution - 0085
Lille 2998324, , 59000
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Local Institution - 0081
Marseille 2995469, , 13011
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Address
Local Institution - 0083
Paris 2988507, , 75010
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Address
Local Institution - 0078
Pierre-Bénite 2987314, , 69310
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Local Institution - 0082
Poitiers 2986495, , 86000
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Local Institution - 0132
Heidelberg 2907911, Baden-Wurttemberg 2953481, 69120
Status
Address
Local Institution - 0131
Tübingen 2820860, Baden-Wurttemberg 2953481, 72076
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Local Institution - 0071
Quedlinburg 2851465, Saxony-Anhalt 2842565, 06484
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Address
Local Institution - 0032
Buxtehude 2940451, , 21614
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Local Institution - 0029
Cologne 2886242, , 50937
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Local Institution - 0030
Erfurt 2929670, , 99089
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Local Institution - 0027
Essen 2928810, , 45147
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Local Institution - 0033
Hanover 2910831, , 30625
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Local Institution - 0074
Homburg / Saar, , 66421
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Local Institution - 0028
Lübeck 2875601, , 23538
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Local Institution - 0072
Mannheim 2873891, , 68167
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Local Institution - 0034
München 2867711, , 81675
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Local Institution - 0031
Würzburg 2805615, , 97080
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Local Institution - 0064
Athens 264371, , 11526
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Local Institution - 0065
Thessaloniki 734077, , 54622
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Local Institution - 0086
Haifa 294801, , 3109601
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Local Institution - 0088
Jerusalem 281184, , 91120
Status
Address
Local Institution - 0087
Ramat Gan 293788, , 52621
Status
Address
Local Institution - 0111
Turin 3165524, Piedmont 3170831, 10126
Status
Address
Local Institution - 0109
Bergamo 3182164, , 24127
Status
Address
Local Institution - 0108
Milan 6951411, , 20133
Status
Address
Local Institution - 0106
Napoli 9031661, , 80131
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Local Institution - 0110
Padua 3171728, , 35128
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Local Institution - 0107
Siena 3166548, , 53100
Status
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Local Institution - 0094
Zapopan 3979770, Jalisco 4004156, 45070
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Address
Local Institution - 0091
Monterrey 3995465, Nuevo León 3522542, 64060
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Address
Local Institution - 0093
Cancún 3531673, Quintana Roo 3520887, 77500
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Local Institution - 0092
Mérida 3523349, Yucatán 3514211, 97130
Status
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Local Institution - 0129
Veracruz 3514783, , 91900
Status
Address
Local Institution - 0090
Dunedin 2191562, , 9012
Status
Address
Local Institution - 0125
Hamilton 2190324, , 3240
Status
Address
Local Institution - 0089
Tauranga 2208032, , 3112
Status
Address
Local Institution - 0121
Oslo 3143244, , 0310
Status
Address
Local Institution - 0040
Poznan 3088171, , 60-780
Status
Address
Local Institution - 0039
Warsaw 756135, , 02-781
Status
Address
Local Institution - 0070
Cluj-Napoca 681290, Cluj 681291, 400015
Status
Address
Local Institution - 0066
Bucharest 683506, , 022328
Status
Address
Local Institution - 0067
Craiova 680332, , 200542
Status
Address
Local Institution - 0069
Iași 675810, , 700483
Status
Address
Local Institution - 0113
Krasnodar 542420, , 350040
Status
Address
Local Institution - 0127
Krasnoyarsk 1502026, , 660133
Status
Address
Local Institution - 0112
Moscow 524901, , 115478
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Address
Local Institution - 0023
A Coruña 3119841, , 15006
Status
Address
Local Institution - 0024
Barcelona 3128760, , 08035
Status
Address
Local Institution - 0025
Barcelona 3128760, , 08036
Status
Address
Local Institution - 0026
Madrid 3117735, , 28034
Status
Address
Local Institution - 0021
San Sabastian Gipuzkoa, , 20014
Status
Address
Local Institution - 0022
Seville 2510911, , 41009
Status
Address
Local Institution - 0098
Gothenburg 2711537, , 413 45
Status
Address
Local Institution - 0099
Lund 2693678, , 221 85
Status
Address
Local Institution - 0118
Solna 2675397, , 171 64
Status
Address
Local Institution - 0122
Uppsala 2666199, , 751 85
Status
Address
Local Institution - 0052
Bristol 2654675, Avon, BS2 8ED
Status
Address
Local Institution - 0054
Glasgow 2648579, Dumfries & Galloway, G12 0YN
Status
Address
Local Institution - 0056
Swansea 2636432, Glamorgan, SA2 8QA
Status
Address
Local Institution - 0051
London 2643743, Greater London, SE1 9RT
Status
Address
Local Institution - 0126
Inverness 2646088, Inverness-shire, IV2 3UJ
