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.

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

790

Study ID:

NCT04099251

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 123 Locations for this study

See Locations Near You

Local Institution - 0088
Birmingham Alabama, 35294, United States
Local Institution - 0126
Tucson Arizona, 85724, United States
Local Institution - 0087
Springdale Arkansas, 72762, United States
Local Institution - 0080
Los Angeles California, 90025, United States
Local Institution - 0077
San Francisco California, 94115, United States
Local Institution - 0119
San Francisco California, 94115, United States
Local Institution - 0122
San Jose California, 95119, United States
Local Institution - 0109
Vallejo California, 94589, United States
Local Institution - 0120
Vallejo California, 94589, United States
Local Institution - 0121
Vallejo California, 94589, United States
Local Institution - 0091
Aurora Colorado, 80045, United States
Local Institution - 0089
Washington District of Columbia, 20057, United States
Local Institution - 0141
Atlanta Georgia, 30342, United States
Local Institution - 0132
Chicago Illinois, 60611, United States
Local Institution - 0135
Baltimore Maryland, 21237, United States
Local Institution - 0078
Boston Massachusetts, 02215, United States
Local Institution - 0127
Boston Massachusetts, 02215, United States
Local Institution - 0143
Boston Massachusetts, 02215, United States
Local Institution - 0081
Robbinsdale Minnesota, 55407, United States
Local Institution - 0079
Omaha Nebraska, 68130, United States
Local Institution - 0093
Hackensack New Jersey, 07601, United States
Local Institution - 0094
New York New York, 10016, United States
Local Institution - 0086
Charlotte North Carolina, 28204, United States
Local Institution - 0099
Cleveland Ohio, 44195, United States
Local Institution - 0076
Portland Oregon, 97213, United States
Local Institution - 0092
Allentown Pennsylvania, 18105, United States
Local Institution - 0031
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0148
Germantown Tennessee, 38138, United States
Local Institution - 0144
Austin Texas, 78731, United States
Local Institution - 0085
Dallas Texas, 75246, United States
Local Institution - 0090
Fairfax Virginia, 22031, United States
Local Institution - 0018
Waratah New South Wales, 2298, Australia
Local Institution - 0025
Westmead New South Wales, 2145, Australia
Local Institution - 0016
Wollstonecraft New South Wales, 2065, Australia
Local Institution - 0105
Cairns Queensland, 4870, Australia
Local Institution - 0017
Greenslopes Queensland, 4120, Australia
Local Institution - 0024
Herston Queensland, 4029, Australia
Local Institution - 0138
Southport Queensland, 4120, Australia
Local Institution - 0019
Box Hill Victoria, 3128, Australia
Local Institution - 0125
Geelong Victoria, 3220, Australia
Local Institution - 0128
Malvern Victoria, 3144, Australia
Local Institution - 0106
Melbourne Victoria, 3004, Australia
Local Institution - 0104
Nedlands Western Australia, 6009, Australia
Local Institution - 0049
Graz , 8036, Austria
Local Institution - 0051
Innsbruck , 6020, Austria
Local Institution - 0050
Salzburg , 5020, Austria
Local Institution - 0048
Wien , 1090, Austria
Local Institution - 0028
Charleroi , 6000, Belgium
Local Institution - 0011
Gent , 9000, Belgium
Local Institution - 0008
Kortrijk , 8500, Belgium
Local Institution - 0010
Liège , 4000, Belgium
Local Institution - 0134
Calgary Alberta, T2N 4, Canada
Local Institution - 0133
Vancouver British Columbia, V5Z 4, Canada
Local Institution - 0131
Halifax Nova Scotia, B3H 2, Canada
Local Institution - 0142
Hamilton Ontario, L8V 5, Canada
Local Institution - 0124
Kingston Ontario, K7L 2, Canada
Local Institution - 0140
Toronto Ontario, M5G 2, Canada
Local Institution - 0116
Montreal Quebec, H2X 3, Canada
Local Institution - 0123
Sherbrooke Quebec, J1H 5, Canada
Local Institution - 0074
Prague Praha 2, 12808, Czechia
Local Institution - 0075
Ostrava-Poruba , 708 5, Czechia
Local Institution - 0073
Praha 10 , 100 3, Czechia
Local Institution - 0007
Aarhus N , 8200, Denmark
Local Institution - 0012
Herlev , 2730, Denmark
Local Institution - 0013
Odense , 5000, Denmark
Local Institution - 0014
Helsinki Etelä-Suomen Lääni, 00290, Finland
Local Institution - 0015
Tampere Pirkanmaa, 33520, Finland
Local Institution - 0110
Turku , 20251, Finland
Local Institution - 0113
Brest Finistère, 29200, France
Local Institution - 0129
Besancon Cedex , 25030, France
Local Institution - 0112
Bordeaux , 33075, France
Local Institution - 0111
Lille , 59037, France
Local Institution - 0033
Marseille , 13011, France
Local Institution - 0035
Nantes , 44000, France
Local Institution - 0130
Nice , 06200, France
Local Institution - 0036
Paris , 75475, France
Local Institution - 0032
Pierre Benite Cedex , 69495, France
Local Institution - 0034
Villejuif , 94800, France
Local Institution - 0056
München Bayern, 81377, Germany
Local Institution - 0072
Bonn , 53127, Germany
Local Institution - 0061
Buxtehude , 21614, Germany
Local Institution - 0098
Dresden , 01307, Germany
Local Institution - 0054
Essen , 45122, Germany
Local Institution - 0062
Gera , 07548, Germany
Local Institution - 0114
Goettingen , 37075, Germany
Local Institution - 0060
Hannover , 30625, Germany
Local Institution - 0055
Heidelberg , 69120, Germany
Local Institution - 0057
Lubeck , 23538, Germany
Local Institution - 0100
Mainz , 55131, Germany
Local Institution - 0102
Regensburg , 93053, Germany
Local Institution - 0058
Tuebingen , 72076, Germany
Local Institution - 0082
Athina , 115 2, Greece
Local Institution - 0084
Piraeus , 185 4, Greece
Local Institution - 0083
Thessaloniki , 57100, Greece
A.O.U. Policlinico Paolo Giaccone
Palermo Sicilia, 90127, Italy
ASST Papa Giovanni XXIII
Bergamo , 24127, Italy
IRCCS Istituto Nazionale Tumori Milano
Milano , 20133, Italy
Istituto Europeo di Oncologia IRCCS
Milano , 20141, Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli , 80131, Italy
Istituto Oncologico Veneto IOV
Padova , 35128, Italy
Azienda Ospedaliera Di Perugia
Perugia , 06132, Italy
Azienda Ospedaliera Universitaria Senese
Siena , 53100, Italy
Local Institution - 0107
Breda , 4819 , Netherlands
Local Institution - 0001
Groningen , 9700R, Netherlands
Local Institution - 0030
Rotterdam , 3015 , Netherlands
Local Institution - 0002
Utrecht , 3584 , Netherlands
Local Institution - 0063
Bergen , 5021, Norway
Local Institution - 0027
Gralum , 1714, Norway
Local Institution - 0005
Oslo , 0310, Norway
Local Institution - 0103
Poznan Wielkopolskie, 60-78, Poland
Local Institution - 0023
Gdansk , 80-21, Poland
Local Institution - 0022
Warszawa , 02-78, Poland
Local Institution - 0047
Cluj-Napoca , 40001, Romania
Local Institution - 0020
Craiova , 20054, Romania
Local Institution - 0021
Sector 2 , 02232, Romania
Local Institution - 0067
A Coruña , 15006, Spain
Local Institution - 0065
Badalona , 08916, Spain
Local Institution - 0071
Barcelona , 08028, Spain
Local Institution - 0066
Madrid , 28034, Spain
Local Institution - 0070
Madrid , 28046, Spain
Local Institution - 0068
Malaga , 29010, Spain
Local Institution - 0064
Santander , 39008, Spain
Local Institution - 0069
Valencia , 46009, Spain
Local Institution - 0026
Orebro , 701 8, Sweden
Local Institution - 0003
Linköping Östergötlands Län [se-05], 581 8, Sweden
Local Institution - 0053
Lausanne , 1011, Switzerland
Local Institution - 0052
Zuerich , 8091, Switzerland
Local Institution - 0044
Cardiff , CF14 , United Kingdom
Local Institution - 0095
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

790

Study ID:

NCT04099251

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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