Melanoma Clinical Trial

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

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.

View Eligibility Criteria

Eligibility Criteria

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. Adolescent participants between 12 and 17 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

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. Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05002569

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 178 Locations for this study

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Local Institution - 0176
Birmingham Alabama, 35233, United States
Local Institution - 0164
Springdale Arkansas, 72762, United States
Local Institution - 0200
Los Angeles California, 90025, United States
Local Institution - 0185
Palo Alto California, 94304, United States
Local Institution - 0162
San Francisco California, 94115, United States
Local Institution - 0138
Aurora Colorado, 80045, United States
Local Institution - 0166
Washington District of Columbia, 20007, United States
Local Institution - 0243
Miami Florida, 33136, United States
Local Institution
Miami Florida, 33136, United States More Info
Site 0182
Contact
Local Institution - 0179
Pensacola Florida, 32504, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa Florida, 33612, United States
Local Institution - 0191
Atlanta Georgia, 30322, United States
Local Institution - 0148
Atlanta Georgia, 30342, United States
Local Institution - 0202
Chicago Illinois, 60611, United States
Local Institution - 0177
Peoria Illinois, 61615, United States
Local Institution - 0223
Fort Wayne Indiana, 46804, United States
University of Iowa-Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States More Info
Yousef Zakharia, Site 0208
Contact
319-384-8076
Local Institution - 0178
Westwood Kansas, 66205, United States
Dana-Farber Cancer Institute-Melanoma
Boston Massachusetts, 02215, United States
Local Institution - 0258
Ann Arbor Michigan, 48109, United States
Local Institution
Grand Rapids Michigan, 49503, United States More Info
Site 0236
Contact
Local Institution - 0133
Minneapolis Minnesota, 55407, United States
Local Institution - 0139
Hackensack New Jersey, 07601, United States
Local Institution - 0206
Morristown New Jersey, 07960, United States
Local Institution - 0140
New York New York, 10016, United States
Icahn School Of Medicine At Mount Sinai
New York New York, 10029, United States
Local Institution - 0210
New York New York, 10065, United States
Local Institution - 0130
Charlotte North Carolina, 28204, United States
Local Institution - 0145
Durham North Carolina, 27710, United States
Local Institution - 0141
Cleveland Ohio, 44195, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus Ohio, 43210, United States
Local Institution - 0267
Allentown Pennsylvania, 18103, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Local Institution - 0125
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0171
Charleston South Carolina, 29425, United States
Local Institution - 0147
Germantown Tennessee, 38138, United States
Local Institution - 0183
Nashville Tennessee, 37232, United States
Local Institution - 0146
Austin Texas, 78731, United States
Local Institution - 0163
Dallas Texas, 75246, United States
Local Institution - 0172
Houston Texas, 77030, United States
Local Institution - 0137
Fairfax Virginia, 22031, United States
Local Institution - 0004
Córdoba Cordoba, X5000, Argentina More Info
Site 0004
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Local Institution - 0001
Caba Distrito Federal, C1430, Argentina More Info
Site 0001
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Local Institution - 0005
Ciudad Autónoma de Buenos Aires Distrito Federal, 1426, Argentina More Info
Site 0005
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Local Institution - 0002
Ciudad de Buenos Aires Distrito Federal, C1121, Argentina More Info
Site 0002
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Local Institution - 0003
Buenos Aires , C1426, Argentina More Info
Site 0003
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Local Institution - 0030
Waratah New South Wales, 2298, Australia
Local Institution - 0252
Westmead New South Wales, 2145, Australia
Local Institution - 0032
Wollstonecraft New South Wales, 2065, Australia
Local Institution - 0254
Tiwi Northern Territory, 0810, Australia
Local Institution - 0028
Brisbane Queensland, 4102, Australia
Local Institution - 0027
Southport Queensland, 4215, Australia
Local Institution - 0250
Woodville South Australia, 5011, Australia
Local Institution
Ballarat Central Victoria, 3350, Australia More Info
Site 0262
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Local Institution - 0035
Ballarat Victoria, 3350, Australia
Local Institution - 0253
Heidelberg Victoria, 3084, Australia
Local Institution - 0031
Melbourne Victoria, 3000, Australia
Local Institution - 0251
Murdoch Western Australia, 6150, Australia
Local Institution - 0029
Perth Western Australia, 6009, Australia
Local Institution - 0082
Graz Steiermark, 8036, Austria More Info
Site 0082
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Local Institution - 0086
Salzburg , 5020, Austria More Info
Site 0086
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Local Institution - 0084
Vienna , 1090, Austria More Info
Site 0084
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Local Institution - 0110
Brussels , 1090, Belgium More Info
Site 0110
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Local Institution - 0105
Brussels , 1200, Belgium More Info
Site 0105
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Local Institution - 0109
Liège , 4000, Belgium More Info
Site 0109
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Local Institution - 0106
Wilrijk , 2610, Belgium More Info
Site 0106
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Local Institution - 0071
Salvador Bahia, 40170, Brazil More Info
Site 0071
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Local Institution - 0072
Fortaleza Ceara, 60135, Brazil More Info
Site 0072
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Local Institution - 0068
Vitória Espirito Santo, 29055, Brazil More Info
Site 0068
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Local Institution - 0047
Belo Horizonte Minas Gerais, 30130, Brazil More Info
Site 0047
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Local Institution - 0056
Ijui Rio Grande Do Sul, 98700, Brazil More Info
Site 0056
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Local Institution - 0257
Porto Alegre RIO Grande DO SUL, 90035, Brazil More Info
Site 0257
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Local Institution - 0049
Porto Alegre RIO Grande DO SUL, 91350, Brazil More Info
Site 0049
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Local Institution - 0048
Santa Cruz do Sul RIO Grande DO SUL, 96830, Brazil More Info
Site 0048
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Local Institution - 0070
Barretos SAO Paulo, 14784, Brazil More Info
Site 0070
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Local Institution - 0058
Rio de Janeiro , 20220, Brazil More Info
Site 0058
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Local Institution - 0175
Vancouver British Columbia, V5Z 4, Canada More Info
Site 0175
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Local Institution - 0197
Halifax Nova Scotia, B3H 2, Canada More Info
Site 0197
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Local Institution - 0144
Toronto Ontario, M5G 2, Canada
Local Institution - 0158
Montreal Quebec, H3T 1, Canada More Info
Site 0158
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Local Institution - 0159
Montréal Quebec, H2X 1, Canada More Info
Site 0159
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Local Institution - 0160
Quebec City Quebec, G1J 1, Canada More Info
Site 0160
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Local Institution - 0198
Sherbrooke Quebec, J1H 5, Canada More Info
Site 0198
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Local Institution - 0155
Edmonton , T6X 1, Canada More Info
Site 0155
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Local Institution - 0013
Santiago Metropolitana, 75100, Chile More Info
Site 0013
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Local Institution - 0006
Santiago Metropolitana, 84203, Chile More Info
Site 0006
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Local Institution - 0014
Santiago Metropolitana, , Chile More Info
Site 0014
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Local Institution - 0221
Hefei Anhui, 23002, China More Info
Site 0221
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Local Institution - 0259
Beijing Beijing, 10003, China More Info
Site 0259
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Local Institution - 0261
Beijing Beijing, 10003, China More Info
Site 0261
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Local Institution - 0214
Beijing Beijing, 10014, China More Info
Site 0214
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Local Institution - 0241
Chongqing Chongqing, 40003, China More Info
Site 0241
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Local Institution - 0245
Fuzhou City Fujian, 35001, China More Info
Site 0245
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Local Institution - 0217
Guangzhou Guangdong, 51006, China More Info
Site 0217
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Local Institution - 0226
Zhengzhou Shi Henan, 45000, China More Info
Site 0226
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Local Institution - 0237
Wuhan Hubei, 43002, China More Info
Site 0237
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Local Institution - 0239
Wuhan Hubei, 43003, China More Info
Site 0239
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Local Institution - 0234
Changsha Shi Hunan, 41001, China More Info
Site 0234
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Local Institution - 0215
Nanjing Jiangsu, 21000, China More Info
Site 0215
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Local Institution - 0224
Nanchang Jiangxi, 33000, China More Info
Site 0224
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Local Institution - 0219
Changchun Jilin, 13002, China More Info
Site 0219
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Local Institution - 0242
Shenyang Liaoning, 11000, China More Info
Site 0242
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Local Institution - 0230
Chengdu Sichuan, 61004, China More Info
Site 0230
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Local Institution
Tianjin Tianjin, 30006, China More Info
Site 0263
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Local Institution - 0228
Urumqi Xinjiang, 83000, China More Info
Site 0228
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Local Institution - 0222
Kunming Yunnan, 43003, China More Info
Site 0222
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Local Institution - 0216
Hangzhou Zhejiang, 31002, China More Info
Site 0216
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Local Institution - 0244
Taiyuan , 03003, China More Info
Site 0244
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Local Institution - 0156
Brno , 65653, Czechia
Local Institution - 0091
Hradec Kralove , 50005, Czechia
Local Institution - 0026
Ostrava , 708 5, Czechia
Local Institution - 0062
Prague , 12808, Czechia
Local Institution - 0016
Aarhus Midtjylland, 8200, Denmark
Local Institution - 0022
Aalborg , 9100, Denmark More Info
Site 0022
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Local Institution - 0018
Copenhagen , 2730, Denmark More Info
Site 0018
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Local Institution - 0020
Odense , 5000, Denmark More Info
Site 0020
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Local Institution - 0007
Helsinki , 00290, Finland More Info
Site 0007
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Local Institution - 0019
Tampere , 33520, Finland More Info
Site 0019
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Local Institution - 0015
Turku , 20521, Finland More Info
Site 0015
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Local Institution - 0040
Villejuif Val-de-Marne, 94800, France
Local Institution - 0043
Dijon , 21000, France
Local Institution - 0044
Marseille , 13385, France
Local Institution - 0039
Nantes , 44093, France
Local Institution - 0042
Paris , 75010, France
Local Institution - 0041
Pierre-Bénite , 69310, France
Local Institution - 0046
Toulouse , 31100, France
Local Institution - 0073
Buxtehude , 21614, Germany More Info
Site 0073
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Local Institution - 0077
Dresden , 01307, Germany More Info
Site 0077
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Local Institution - 0074
Erlangen , 91054, Germany More Info
Site 0074
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Local Institution - 0131
Essen , 45147, Germany More Info
Site 0131
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Local Institution - 0081
Gera , 0, Germany More Info
Site 0081
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Local Institution - 0079
Hannover , 30625, Germany More Info
Site 0079
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Local Institution - 0075
Heidelberg , D-691, Germany More Info
Site 0075
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Local Institution - 0078
Lübeck , 23538, Germany More Info
Site 0078
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Local Institution - 0083
Minden , 32429, Germany More Info
Site 0083
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Local Institution - 0076
Munich , 80337, Germany More Info
Site 0076
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Local Institution - 0092
Tübingen , 72076, Germany More Info
Site 0092
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Local Institution - 0080
Wuerzburg , 97080, Germany More Info
Site 0080
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Local Institution - 0114
Athens , 11527, Greece More Info
Site 0114
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Local Institution - 0113
Neo Faliro , 185 4, Greece More Info
Site 0113
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Local Institution - 0112
Thessaloniki , 540 0, Greece More Info
Site 0112
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Local Institution - 0116
Afula , 18341, Israel More Info
Site 0116
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Local Institution - 0118
Jerusalem , 91120, Israel More Info
Site 0118
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Local Institution - 0199
Ramag Gan , 52620, Israel More Info
Site 0199
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Local Institution - 0117
Ramat Gan , 52621, Israel More Info
Site 0117
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Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica del Melanoma, Sarcoma e Tumori Rar
Milano , 20141, Italy More Info
Paola Queirolo, Site 0123
Contact
390105600384
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan , 20133, Italy More Info
Michele Del Vecchio, Site 0115
Contact
+390223902897
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan , 20133, Italy More Info
Stefano Chiaravalli, Site 0268
Contact
+390223902588
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
Napoli , 80131, Italy More Info
Paolo Ascierto, Site 0119
Contact
390815903431
Istituto Oncologico Veneto IRCCS-Oncologia del Melenoma
Padova , 35128, Italy More Info
Vanna Chiarion-Sileni, Site 0120
Contact
0039 0498215938
Azienda Ospedaliera Di Perugia
Perugia , 06132, Italy More Info
Mario Mandala, Site 0122
Contact
00393386605619
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena , 53100, Italy More Info
Michele Maio, Site 0121
Contact
390577586335
Local Institution - 0100
Benito Juarez Distrito Federal, 03240, Mexico More Info
Site 0100
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Local Institution - 0021
Zapopan Jalisco, 45070, Mexico More Info
Site 0021
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Local Institution - 0093
Mexico Nuevo LEON, 64320, Mexico More Info
Site 0093
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Local Institution - 0098
Oaxaca , 68020, Mexico More Info
Site 0098
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Local Institution - 0009
Lørenskog Akershus, 1478, Norway More Info
Site 0009
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Local Institution - 0017
Oslo , 0310, Norway More Info
Site 0017
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Local Institution - 0023
Stavanger , 4011, Norway More Info
Site 0023
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Local Institution - 0249
Coimbra , 3000-, Portugal
Local Institution - 0247
Lisbon , 1099-, Portugal
Local Institution - 0248
Lisbon , 1649-, Portugal
Local Institution - 0246
Porto , 4200-, Portugal
Local Institution - 0170
Brasov , 50028, Romania
Local Institution - 0065
Cluj , 40001, Romania
Local Institution - 0066
Craiova , 20054, Romania
Local Institution - 0064
Floresti/ Cluj , 40728, Romania
Local Institution - 0067
Iasi , 70011, Romania
Local Institution - 0188
Badajoz , 06071, Spain
Local Institution - 0201
Barcelona , 08035, Spain
Local Institution - 0153
Granada , 18012, Spain
Local Institution - 0150
Madrid , 28009, Spain
Local Institution - 0151
San Sebastian , 20014, Spain
Local Institution - 0152
València , 46026, Spain
Local Institution - 0010
Gothenburg , 41345, Sweden More Info
Site 0010
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Local Institution - 0011
Lund , 221 8, Sweden More Info
Site 0011
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Local Institution - 0012
Solna , 171 6, Sweden More Info
Site 0012
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Local Institution - 0085
Basel , 4031, Switzerland More Info
Site 0085
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Local Institution - 0087
Chur , 7000, Switzerland More Info
Site 0087
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Local Institution - 0090
Zürich , 8091, Switzerland More Info
Site 0090
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Local Institution - 0187
Glasgow Lanarkshire, G12 0, United Kingdom More Info
Site 0187
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Local Institution - 0101
Nottingham Nottinghamshire, NG5 1, United Kingdom More Info
Site 0101
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Local Institution - 0102
Bristol , BS2 8, United Kingdom More Info
Site 0102
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Local Institution - 0154
Newcastle upon Tyne , NE7 7, United Kingdom More Info
Site 0154
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Local Institution - 0232
Oxford , OX3 7, United Kingdom More Info
Site 0232
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Local Institution - 0127
Southampton , SO16 , United Kingdom More Info
Site 0127
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Local Institution - 0107
Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05002569

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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