NCT05002569
Recruiting
August 12, 2021
May 13, 2022
Brief summary:
The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Arm B: Nivolumab Monotherapy |
Biological: Nivolumab Specified dose on specified days |
Experimental: Arm A: Relatlimab + Nivolumab Combination |
Biological: Relatlimab + Nivolumab Fixed Dose Combination Specified dose on specified days |
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 must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Complete resection must be performed within 12 weeks 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 uveal 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 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria apply
Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com/ 855-907-3286 Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT # and Site #.
United States, Alabama
Local Institution
Birmingham
United States, Arkansas
Highlands Oncology Group-Research Department
Springdale
United States, California
Local Institution
Los Angeles
United States, California
Local Institution
Palo Alto
United States, California
San Francisco Oncology Associates
San Francisco
United States, Colorado
Local Institution
Aurora
United States, District of Columbia
Local Institution
Washington
United States, Florida
Local Institution
Miami
United States, Florida
Local Institution
Miami
United States, Florida
Sacred Heart Medical Group
Pensacola
United States, Florida
Local Institution
Tampa
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta
United States, Georgia
Northside Hospital
Atlanta
United States, Illinois
Local Institution
Chicago
United States, Illinois
Local Institution
Peoria
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne
United States, Iowa
Local Institution
Iowa City
United States, Kansas
Local Institution
Kansas City
United States, Massachusetts
Local Institution
Boston
United States, Michigan
Local Institution
Ann Arbor
United States, Michigan
Local Institution
Grand Rapids
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis
United States, New Jersey
Local Institution
Hackensack
United States, New Jersey
Local Institution
Morristown
United States, New York
NYU Langone Health-Perlmutter Cancer Center
New York
United States, New York
Local Institution
New York
United States, New York
Memorial Sloan Kettering Nassau
New York
United States, North Carolina
Levine Cancer Institute-Cutaneous Malignancies/Immunotherapy
Charlotte
United States, North Carolina
Duke Cancer Institute
Durham
United States, Ohio
Local Institution
Cleveland
United States, Ohio
Local Institution
Columbus
United States, Pennsylvania
Local Institution
Philadelphia
United States, Pennsylvania
Local Institution
Pittsburgh
United States, South Carolina
Local Institution
Charleston
United States, Tennessee
The West Clinic
Germantown
United States, Tennessee
Local Institution
Nashville
United States, Texas
Local Institution
Austin
United States, Texas
Local Institution
Dallas
United States, Texas
University of Texas MD Anderson Cancer Center-Melanoma Medical Oncology
Houston
United States, Virginia
Local Institution
Fairfax
Argentina, Distrito Federal
Local Institution - 0001
Caba
Argentina, Distrito Federal
Local Institution - 0005
Ciudad Autónoma de Buenos Aires
Argentina, Distrito Federal
Local Institution - 0002
Ciudad de Buenos Aires
Argentina
Local Institution - 0003
Buenos Aires
Argentina
Local Institution
Cordoba
Australia, New South Wales
Local Institution
Waratah
Australia, New South Wales
Local Institution
Westmead
Australia, New South Wales
Local Institution - 0032
Wollstonecraft
Australia, Northern Territory
Local Institution
Tiwi
Australia, Queensland
Local Institution - 0028
Brisbane
Australia, Queensland
Local Institution - 0027
Southport
Australia, South Australia
Local Institution
Woodville South
Australia, Victoria
Local Institution
Ballarat Central
Australia, Victoria
Local Institution
Ballarat Central
Australia, Victoria
Local Institution
Heidelberg
Australia, Victoria
Local Institution - 0031
Melbourne
Australia, Western Australia
Local Institution
Murdoch
Australia, Western Australia
Local Institution
Nedlands
Austria
Local Institution - 0082
Graz
Austria
Local Institution - 0086
Salzburg
Austria
Local Institution - 0084
Vienna
Belgium
Local Institution
Brussels
Belgium
Local Institution - 0105
Brussels
Belgium
Local Institution - 0109
Liège
Belgium
Local Institution
Wilrijk
Brazil, Bahia
Local Institution
Salvador
Brazil, Ceara
Local Institution
Fortaleza
Brazil, Espirito Santo
Local Institution
Vitória
Brazil, Minas Gerais
Local Institution
BH
Brazil, RIO Grande DO SUL
Local Institution
Ijui
Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre
Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre
Brazil, RIO Grande DO SUL
Local Institution - 0048
Santa Cruz do Sul
Brazil, SAO Paulo
Local Institution
Barretos
Brazil
Local Institution
Rio de Janeiro
Canada, Alberta
Local Institution
Edmonton
Canada, British Columbia
Local Institution
Vancouver
Canada, Nova Scotia
Local Institution
Halifax
Canada, Ontario
Local Institution
Toronto
Canada, Quebec
Local Institution
Montreal
Canada, Quebec
Local Institution
Sherbrooke
Canada
Local Institution
Montréal
Canada
Local Institution
Quebec
Chile, Metropolitana
Local Institution - 0013
Santiago
Chile, Metropolitana
Local Institution
Santiago
Chile, Metropolitana
Local Institution - 0006
Santiago
China, Beijing
Local Institution
Beijing
China, Guangdong
Local Institution
Guangzhou
China, Henan
Local Institution
Zhengzhou
China, Hubei
Local Institution
Wuhan Shi
China, Jiangsu
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Nanjing
China, Sichuan
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Chengdu
China, Tianjin
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Tianjin
China, Xinjiang
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Urumqi
China, Zhejiang
Local Institution
Hangzhou
Czechia
Local Institution - 0156
Brno
Czechia
Local Institution - 0091
Hradec Kralove
Czechia
Local Institution - 0026
Ostrava
Czechia
Local Institution - 0062
Prague
Denmark
Local Institution
Aalborg
Denmark
Local Institution
Aarhus N
Denmark
Local Institution
Herlev
Denmark
Local Institution - 0020
Odense
Finland
Local Institution - 0007
Helsinki
Finland
Local Institution
Tampere
Finland
Local Institution
Turku
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 - 0040
Villejuif
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 - 0079
Hannover
Germany
Local Institution - 0075
Heidelberg
Germany
Local Institution - 0078
Lübeck
Germany
Local Institution - 0083
Minden
Germany
Local Institution - 0076
Munich
Germany
Local Institution - 0092
Tübingen
Germany
Universitaetsklinikum Wuerzburg-Department of Dermatology
Wuerzburg
Greece
Local Institution - 0114
Athens
Greece
Local Institution
Piraeus
Greece
Local Institution
Thessaloniki
Israel
Local Institution - 0116
Afula
Israel
Local Institution
Jerusalem
Israel
Local Institution - 0199
Ramag Gan
Israel
Local Institution - 0117
Ramat Gan
Italy
Local Institution - 0123
Milano
Italy
Local Institution - 0115
Milan
Italy
Local Institution - 0119
Napoli
Italy
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Padova
Italy
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Perugia
Italy
Local Institution - 0121
Siena
Mexico, Distrito Federal
Local Institution - 0100
Benito Juarez
Mexico, Jalisco
Local Institution - 0021
Zapopan
Mexico, Nuevo LEON
Local Institution - 0093
Mexico
Mexico
Local Institution - 0098
Oaxaca
Norway
Local Institution
Lorenskog
Norway
Local Institution - 0017
Oslo
Norway
Local Institution - 0023
Stavanger
Portugal
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Coimbra
Portugal
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Lisboa
Portugal
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Lisbon
Portugal
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Porto
Romania
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Brasov
Romania
Local Institution
Cluj-Napoca
Romania
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Craiova
Romania
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Floresti/ Cluj
Romania
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Iasi
Spain
Local Institution - 0188
Badajoz
Spain
Local Institution
Barcelona
Spain
Local Institution - 0153
Granada
Spain
Local Institution - 0150
Madrid
Spain
Local Institution - 0151
San Sebastian
Spain
Local Institution - 0152
València
Sweden
Local Institution
Goteborg
Sweden
Local Institution - 0011
Lund
Sweden
Local Institution
Stockholm
Switzerland
University Hospital Basel
Basel
Switzerland
Kantonsspital Graubünden-Medizin
Chur
Switzerland
Local Institution - 0090
Zürich
United Kingdom
Local Institution
Bristol
United Kingdom
Local Institution
Glasgow
United Kingdom
Local Institution
Nottingham
United Kingdom
Local Institution - 0232
Oxford
United Kingdom
Local Institution
Southampton
United Kingdom
Local Institution
Swansea
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb