Melanoma Clinical Trial
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Summary
The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Eligibility Criteria
Inclusion Criteria:
Had a negative sentinel lymph node biopsy
Participant has not been previously treated for melanoma
ECOG 0 or 1
Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma
Exclusion Criteria:
History of ocular or mucosal melanoma.
Pregnant or nursing women
Participants with active known or suspected autoimmune disease
Known history of allergy or hypersensitivity to study drug components
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways
Other protocol defined inclusion/exclusion criteria apply.
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There are 129 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85724, United States
Springdale Arkansas, 72762, United States
Los Angeles California, 90025, United States
San Francisco California, 94115, United States
San Francisco California, 94115, United States
San Jose California, 95119, United States
Vallejo California, 94589, United States
Vallejo California, 94589, United States
Vallejo California, 94589, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20057, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60611, United States
Baltimore Maryland, 21237, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Robbinsdale Minnesota, 55407, United States
Omaha Nebraska, 68130, United States
Hackensack New Jersey, 07601, United States
New York New York, 10016, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18105, United States
Pittsburgh Pennsylvania, 15232, United States
Germantown Tennessee, 38138, United States
Austin Texas, 78731, United States
Dallas Texas, 75246, United States
Fairfax Virginia, 22031, United States
Macquarie University New South Wales, 2109, Australia
Waratah New South Wales, 2298, Australia
Wollstonecraft New South Wales, 2065, Australia
Cairns Queensland, 4870, Australia
Greenslopes Queensland, 4120, Australia
Herston Queensland, 4029, Australia
Southport Queensland, 4120, Australia
Box Hill Victoria, 3128, Australia
Geelong Victoria, 3220, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3004, Australia
Nedlands Western Australia, 6009, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Liège , 4000, Belgium
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Prague Praha 2, 12808, Czechia
Ostrava-Poruba , 708 5, Czechia
Praha 10 , 100 3, Czechia
Aarhus N , 8200, Denmark
Herlev , 2730, Denmark
Odense , 5000, Denmark
Tampere Pirkanmaa, 33520, Finland
Helsinki , 00290, Finland
Turku , 20520, Finland
Brest Finistère, 29200, France
Besancon Cedex , 25030, France
Bordeaux , 33075, France
Lille , 59037, France
Marseille , 13011, France
Nantes , 44000, France
Nice , 06200, France
Paris , 75475, France
Pierre Benite Cedex , 69495, France
Villejuif , 94800, France
München Bayern, 81377, Germany
Bonn , 53127, Germany
Buxtehude , 21614, Germany
Dresden , 01307, Germany
Essen , 45122, Germany
Gera , 07548, Germany
Goettingen , 37075, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Lubeck , 23538, Germany
Mainz , 55131, Germany
Regensburg , 93053, Germany
Tuebingen , 72076, Germany
Athina , 115 2, Greece
Piraeus , 185 4, Greece
Thessaloniki , 57100, Greece
Palermo Sicilia, 90127, Italy
Bergamo , 24127, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Perugia , 06132, Italy
Siena , 53100, Italy
Breda , 4819 , Netherlands
Groningen , 9700R, Netherlands
Rotterdam , 3015 , Netherlands
Utrecht , 3584 , Netherlands
Bergen , 5021, Norway
Gralum , 1714, Norway
Oslo , 0310, Norway
Poznan Wielkopolskie, 60-78, Poland
Gdansk , 80-21, Poland
Warszawa , 02-78, Poland
Cluj-Napoca , 40001, Romania
Craiova , 20054, Romania
Sector 2 , 02232, Romania
A Coruña , 15006, Spain
Badalona , 08916, Spain
Barcelona , 08028, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Santander , 39008, Spain
Valencia , 46009, Spain
Orebro , 701 8, Sweden
Linköping Östergötlands Län [se-05], 581 8, Sweden
Lausanne , 1011, Switzerland
Zuerich , 8091, Switzerland
London England, SW17 , United Kingdom
Glasgow Lanarkshire, G12 0, United Kingdom
Cardiff , CF14 , United Kingdom
Edinburgh , EH4 2, United Kingdom
Leicester , LE1 5, United Kingdom
London , NW3 2, United Kingdom
Southampton , SO16 , United Kingdom
Stoke-on-Trent , ST4 6, United Kingdom
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