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.
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 < 18 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
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There are 178 Locations for this study
Birmingham Alabama, 35233, United States
Springdale Arkansas, 72762, United States
Los Angeles California, 90025, United States
Palo Alto California, 94304, United States
San Francisco California, 94115, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Pensacola Florida, 32504, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60611, United States
Peoria Illinois, 61615, United States
Fort Wayne Indiana, 46804, United States
Iowa City Iowa, 52242, United States More Info
Westwood Kansas, 66205, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Minneapolis Minnesota, 55407, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07960, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Allentown Pennsylvania, 18103, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29425, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78731, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Córdoba Cordoba, X5000, Argentina
Caba Distrito Federal, C1430, Argentina
Ciudad Autónoma de Buenos Aires Distrito Federal, 1426, Argentina
Ciudad de Buenos Aires Distrito Federal, C1121, Argentina
Buenos Aires , C1426, Argentina
Waratah New South Wales, 2298, Australia
Westmead New South Wales, 2145, Australia
Wollstonecraft New South Wales, 2065, Australia
Tiwi Northern Territory, 0810, Australia
Brisbane Queensland, 4102, Australia
Southport Queensland, 4215, Australia
Woodville South Australia, 5011, Australia
Ballarat Victoria, 3350, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Murdoch Western Australia, 6150, Australia
Perth Western Australia, 6009, Australia
Graz Steiermark, 8036, Austria
Salzburg , 5020, Austria
Vienna , 1090, Austria
Brussels , 1090, Belgium
Bruxelles , 1200, Belgium
Liège , 4000, Belgium
Wilrijk , 2610, Belgium
Salvador Bahia, 40170, Brazil
Fortaleza Ceara, 60135, Brazil
Vitória Espirito Santo, 29055, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Santa Cruz do Sul RIO Grande DO SUL, 96830, Brazil
Barretos SAO Paulo, 14784, Brazil
Rio de Janeiro , 20220, Brazil
Edmonton Alberta, T6X 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Montréal Quebec, H2X 1, Canada
Quebec City Quebec, G1J 1, Canada
Sherbrooke Quebec, J1H 5, Canada
Santiago Metropolitana, 75100, Chile
Santiago Metropolitana, 84203, Chile
Santiago Metropolitana, , Chile
Brno , 65653, Czechia
Hradec Kralove , 50005, Czechia
Ostrava , 708 5, Czechia
Prague , 12808, Czechia
Aarhus Midtjylland, 8200, Denmark
Aalborg , 9100, Denmark
Copenhagen , 2730, Denmark
Odense , 5000, Denmark
Helsinki , 00290, Finland
Tampere , 33520, Finland
Turku , 20521, Finland
Villejuif Val-de-Marne, 94800, France
Dijon , 21000, France
Marseille , 13385, France
Nantes , 44093, France
Paris , 75010, France
Pierre-Bénite , 69310, France
Toulouse , 31100, France
Tübingen Baden-Württemberg, 72076, Germany
Hannover Lower Saxony, 30625, Germany
Buxtehude , 21614, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Gera , 07548, Germany
Heidelberg , D-691, Germany
Lübeck , 23538, Germany
Minden , 32429, Germany
Munich , 80337, Germany
Wuerzburg , 97080, Germany
Athens , 11527, Greece
Neo Faliro , 185 4, Greece
Thessaloniki , 540 0, Greece
Jerusalem Yerushalayim, 91120, Israel
Afula , 18341, Israel
Ramag Gan , 52620, Israel
Ramat Gan , 52621, Israel
Milano , 20141, Italy
Milan , 20133, Italy
Milan , 20133, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Perugia , 06132, Italy
Siena , 53100, Italy
Benito Juarez Distrito Federal, 03240, Mexico
Zapopan Jalisco, 45070, Mexico
Mexico Nuevo LEON, 64320, Mexico
Oaxaca , 68020, Mexico
Lørenskog Akershus, 1478, Norway
Oslo , 0310, Norway
Stavanger , 4011, Norway
Coimbra , 3000-, Portugal
Lisbon , 1099-, Portugal
Lisbon , 1649-, Portugal
Porto , 4200-, Portugal
Brasov , 50028, Romania
Cluj , 40001, Romania
Craiova , 20054, Romania
Floresti/ Cluj , 40728, Romania
Iasi , 70011, Romania
Badajoz , 06071, Spain
Barcelona , 08035, Spain
Granada , 18012, Spain
Madrid , 28009, Spain
San Sebastian , 20014, Spain
València , 46026, Spain
Gothenburg , 41345, Sweden
Lund , 221 8, Sweden
Solna , 171 6, Sweden
Basel , 4031, Switzerland
Chur , 7000, Switzerland
Zürich , 8091, Switzerland
Glasgow Lanarkshire, G12 0, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Bristol , BS2 8, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
Oxford , OX3 7, United Kingdom
Southampton , SO16 , United Kingdom
Swansea , SA2 8, United Kingdom
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