Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
NCT ID: NCT04099251
Last Updated: 2025-08-27
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
790 participants
INTERVENTIONAL
2019-10-28
2027-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nivolumab
Nivolumab
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0088
Birmingham, Alabama, United States
Local Institution - 0126
Tucson, Arizona, United States
Local Institution - 0087
Springdale, Arkansas, United States
Local Institution - 0080
Los Angeles, California, United States
Local Institution - 0077
San Francisco, California, United States
Local Institution - 0119
San Francisco, California, United States
Local Institution - 0122
San Jose, California, United States
Local Institution - 0121
Vallejo, California, United States
Local Institution - 0109
Vallejo, California, United States
Local Institution - 0120
Vallejo, California, United States
Local Institution - 0091
Aurora, Colorado, United States
Local Institution - 0089
Washington D.C., District of Columbia, United States
Local Institution - 0141
Atlanta, Georgia, United States
Local Institution - 0132
Chicago, Illinois, United States
Local Institution - 0135
Baltimore, Maryland, United States
Local Institution - 0078
Boston, Massachusetts, United States
Local Institution - 0127
Boston, Massachusetts, United States
Local Institution - 0143
Boston, Massachusetts, United States
Local Institution - 0151
Minneapolis, Minnesota, United States
Local Institution - 0081
Robbinsdale, Minnesota, United States
Local Institution - 0079
Omaha, Nebraska, United States
Local Institution - 0093
Hackensack, New Jersey, United States
Local Institution - 0094
New York, New York, United States
Local Institution - 0086
Charlotte, North Carolina, United States
Local Institution - 0099
Cleveland, Ohio, United States
Local Institution - 0076
Portland, Oregon, United States
Local Institution - 0092
Allentown, Pennsylvania, United States
Local Institution - 0031
Pittsburgh, Pennsylvania, United States
Local Institution - 0148
Germantown, Tennessee, United States
Local Institution - 0144
Austin, Texas, United States
Local Institution - 0085
Dallas, Texas, United States
Local Institution - 0090
Fairfax, Virginia, United States
Local Institution - 0018
Waratah, New South Wales, Australia
Local Institution - 0025
Westmead, New South Wales, Australia
Local Institution - 0016
Wollstonecraft, New South Wales, Australia
Local Institution - 0105
Cairns, Queensland, Australia
Local Institution - 0017
Greenslopes, Queensland, Australia
Local Institution - 0024
Herston, Queensland, Australia
Local Institution - 0138
Southport, Queensland, Australia
Local Institution - 0019
Box Hill, Victoria, Australia
Local Institution - 0125
Geelong, Victoria, Australia
Local Institution - 0128
Malvern, Victoria, Australia
Local Institution - 0106
Melbourne, Victoria, Australia
Local Institution - 0104
Nedlands, Western Australia, Australia
Local Institution - 0049
Graz, , Austria
Local Institution - 0051
Innsbruck, , Austria
Local Institution - 0050
Salzburg, , Austria
Local Institution - 0048
Vienna, , Austria
Local Institution - 0028
Charleroi, , Belgium
Local Institution - 0011
Ghent, , Belgium
Local Institution - 0008
Kortrijk, , Belgium
Local Institution - 0010
Liège, , Belgium
Local Institution - 0134
Calgary, Alberta, Canada
Local Institution - 0133
Vancouver, British Columbia, Canada
Local Institution - 0131
Halifax, Nova Scotia, Canada
Local Institution - 0142
Hamilton, Ontario, Canada
Local Institution - 0124
Kingston, Ontario, Canada
Local Institution - 0140
Toronto, Ontario, Canada
Local Institution - 0116
Montreal, Quebec, Canada
Local Institution - 0123
Sherbrooke, Quebec, Canada
Local Institution - 0074
Prague, Praha 2, Czechia
Local Institution - 0075
Ostrava-Poruba, , Czechia
Local Institution - 0073
Prague, , Czechia
Local Institution - 0007
Aarhus N, , Denmark
Local Institution - 0012
Herlev, , Denmark
Local Institution - 0013
Odense, , Denmark
Local Institution - 0014
Helsinki, Etelä-Suomen Lääni, Finland
Local Institution - 0015
Tampere, Pirkanmaa, Finland
Local Institution - 0110
Turku, , Finland
Local Institution - 0113
Brest, Finistère, France
Local Institution - 0129
Besançon, , France
Local Institution - 0112
Bordeaux, , France
Local Institution - 0111
Lille, , France
Local Institution - 0033
Marseille, , France
Local Institution - 0035
Nantes, , France
Local Institution - 0130
Nice, , France
Local Institution - 0036
Paris, , France
Local Institution - 0032
Pierre-Bénite, , France
Local Institution - 0034
Villejuif, , France
Local Institution - 0056
München, Bavaria, Germany
Local Institution - 0072
Bonn, , Germany
Local Institution - 0061
Buxtehude, , Germany
Local Institution - 0098
Dresden, , Germany
Local Institution - 0054
Essen, , Germany
Local Institution - 0062
Gera, , Germany
Local Institution - 0114
Göttingen, , Germany
Local Institution - 0060
Hanover, , Germany
Local Institution - 0055
Heidelberg, , Germany
Local Institution - 0057
Lübeck, , Germany
Local Institution - 0100
Mainz, , Germany
Local Institution - 0102
Regensburg, , Germany
Local Institution - 0058
Tübingen, , Germany
Local Institution - 0084
Athens, Attikí, Greece
Local Institution - 0082
Athens, , Greece
Local Institution - 0083
Thessaloniki, , Greece
Local Institution - 0046
Palermo, Sicily, Italy
Local Institution - 0040
Bergamo, , Italy
Local Institution - 0037
Milan, , Italy
Local Institution - 0146
Milan, , Italy
Local Institution - 0101
Napoli, , Italy
Local Institution - 0039
Padua, , Italy
Local Institution - 0145
Perugia, , Italy
Local Institution - 0038
Siena, , Italy
Local Institution - 0107
Breda, , Netherlands
Local Institution - 0001
Groningen, , Netherlands
Local Institution - 0030
Rotterdam, , Netherlands
Local Institution - 0002
Utrecht, , Netherlands
Local Institution - 0063
Bergen, , Norway
Local Institution - 0027
Grålum, , Norway
Local Institution - 0005
Oslo, , Norway
Local Institution - 0103
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0023
Gdansk, , Poland
Local Institution - 0022
Warsaw, , Poland
Local Institution - 0047
Cluj-Napoca, , Romania
Local Institution - 0020
Craiova, , Romania
Local Institution - 0021
Sector 2, , Romania
Local Institution - 0071
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0067
A Coruña, , Spain
Local Institution - 0065
Badalona, , Spain
Local Institution - 0066
Madrid, , Spain
Local Institution - 0070
Madrid, , Spain
Local Institution - 0068
Málaga, , Spain
Local Institution - 0064
Santander, , Spain
Local Institution - 0069
Valencia, , Spain
Local Institution - 0026
Örebro, , Sweden
Local Institution - 0003
Linköping, Östergötlands Län [se-05], Sweden
Local Institution - 0053
Lausanne, , Switzerland
Local Institution - 0052
Zurich, , Switzerland
Local Institution - 0044
Cardiff, , United Kingdom
Local Institution - 0095
Southampton, , United Kingdom
Countries
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References
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Kirkwood JM, Mohr P, Hoeller C, Grob JJ, Del Vecchio M, Lord-Bessen J, Srinivasan S, Nassar A, Campigotto F, Fairbanks H, Taylor F, Lawrance R, Long GV, Weber J. Patient-reported outcomes with adjuvant nivolumab versus placebo after complete resection of stage IIB/C melanoma in the randomized phase 3 CheckMate 76 K trial. Eur J Cancer. 2025 May 2;220:115371. doi: 10.1016/j.ejca.2025.115371. Epub 2025 Mar 19.
Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J, Rutkowski P, Arenberger P, Quereux G, Meniawy TM, Ascierto PA, Menzies AM, Durani P, Lobo M, Campigotto F, Gastman B, Long GV. Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med. 2023 Nov;29(11):2835-2843. doi: 10.1038/s41591-023-02583-2. Epub 2023 Oct 16.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-001230-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1229-8927
Identifier Type: OTHER
Identifier Source: secondary_id
CA209-76K
Identifier Type: -
Identifier Source: org_study_id
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