An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
NCT ID: NCT03068455
Last Updated: 2021-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1844 participants
INTERVENTIONAL
2017-04-11
2021-02-02
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
DOUBLE
Study Groups
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nivolumab + ipilimumab
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
ipilimumab
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
Interventions
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nivolumab
Specified Dose on Specified Days
ipilimumab
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
* No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
Exclusion Criteria
* Patients with active, known or suspected autoimmune disease
* Prior treatment with interferon (if complete \< 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation 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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University of Arizona Cancer Center
Tucson, Arizona, United States
The Angeles Clinic & Research Institute
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University Of Colorado
Aurora, Colorado, United States
Georgetown University Med Ctr
Washington D.C., District of Columbia, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Mass General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School Of Medicine
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Providence Cancer Center Oncology And Hematology Care
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
St. Luke's University Health Network
Easton, Pennsylvania, United States
Local Institution
Nashville, Tennessee, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
Md Anderson Can Cnt
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, United States
University Of Washington Cancer Care Alliance
Seattle, Washington, United States
Local Institution
North Sydney, New South Wales, Australia
Local Institution
Waratah, New South Wales, Australia
Local Institution
Westmead, New South Wales, Australia
Local Institution
Greenslopes, Queensland, Australia
Local Institution
Southport, Queensland, Australia
Local Institution
Woolloongabba, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Box Hill, Victoria, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Nedlands, Western Australia, Australia
Local Institution
Subiaco, Western Australia, Australia
Local Institution
Graz, , Austria
Local Institution
Vienna, , Austria
Local Institution
Brussels, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Ghent, , Belgium
Local Institution
Liège, , Belgium
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil
Local Institution
Ijuí, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Florianópolis, Santa Catarina, Brazil
Local Institution
Barretos, São Paulo, Brazil
Local Institution
São José do Rio Preto, São Paulo, Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, Canada
Klinika komplexni onkologicke pece
Brno, , Czechia
Klinika onkologie a radioterapie
Hradec Králové, , Czechia
Dermatovenerologicka klinika 3. LF UK a FNKV
Prague, , Czechia
Dermatovenerologicka klinika VFN a 1. LF UK
Prague, , Czechia
Centre Hospitalier Universitaire Dijon Bocage
Dijon, , France
Hopital Claude Huriez
Lille, , France
Hopital De La Timone
Marseille, , France
Chu Nantes
Nantes, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Local Institution
Berlin, , Germany
Local Institution
Buxtehude, , Germany
Local Institution
Essen, , Germany
Local Institution
Gera, , Germany
Local Institution
Hanover, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Lübeck, , Germany
Local Institution
München, , Germany
Local Institution
Tübingen, , Germany
Laiko Hospital
Athens, , Greece
Metropolitan Hospital
Athens, , Greece
Local Institution
Haifa, , Israel
Local Institution
Jerusalem, , Israel
Local Institution
Tel Litwinsky, , Israel
ASST Papa Giovanni XXIII
Bergamo, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
IRCCS Istituto Nazionale Tumori Milano
Milan, , Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, , Italy
Istituto Oncologico Veneto IOV
Padua, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Local Institution
Tauranga, Bay of Plenty, New Zealand
Local Institution
Christchurch, , New Zealand
Local Institution
Dunedin, , New Zealand
Klinika Nowotworow Ukladowych i Uogolnionych
Krakow, , Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, , Poland
Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
Bucharest, , Romania
Sf. Nectarie Oncology Center
Craiova, , Romania
Local Institution
Krasnodar, , Russia
Local Institution
Krasnoyarsk, , Russia
Local Institution
Moscow, , Russia
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona, , Spain
H. Univ. Vall dHebron
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Gral. Univ. Gregorio Maranon
Madrid, , Spain
Hospital Regional Universitario De Malaga
Málaga, , Spain
Hosp Univ Virgen Macarena
Seville, , Spain
Hospital Universitario Y Politecnico La Fe
Valencia, , Spain
Local Institution
Lausanne, , Switzerland
Local Institution
Zurich, , Switzerland
Local Institution
Oxford, Oxfordshire, United Kingdom
The Beatson West Of Scotland Cancer Centre
Glasgow, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Christie Hospital Nhs Trust
Manchester, , United Kingdom
Royal Marsden Hospital - Surrey
Sutton, , United Kingdom
Countries
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References
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Long GV, Tang H, Desai K, Wang S, Del Vecchio M, Larkin J, Ritchings C, Huang SP, Baden J, Balli D, Chang H, Fusaro G, Tenney D, Dolfi S, Weber J. Pretreatment and on-treatment ctDNA and tissue biomarkers predict recurrence in patients with stage IIIB-D/IV melanoma treated with adjuvant immunotherapy: CheckMate 915. J Immunother Cancer. 2025 Jul 11;13(7):e012034. doi: 10.1136/jitc-2025-012034.
Weber JS, Schadendorf D, Del Vecchio M, Larkin J, Atkinson V, Schenker M, Pigozzo J, Gogas H, Dalle S, Meyer N, Ascierto PA, Sandhu S, Eigentler T, Gutzmer R, Hassel JC, Robert C, Carlino MS, Di Giacomo AM, Butler MO, Munoz-Couselo E, Brown MP, Rutkowski P, Haydon A, Grob JJ, Schachter J, Queirolo P, de la Cruz-Merino L, van der Westhuizen A, Menzies AM, Re S, Bas T, de Pril V, Braverman J, Tenney DJ, Tang H, Long GV. Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915). J Clin Oncol. 2023 Jan 20;41(3):517-527. doi: 10.1200/JCO.22.00533. Epub 2022 Sep 26.
Yoshino T, Oki E, Misumi T, Kotaka M, Manaka D, Eto T, Hasegawa J, Takagane A, Nakamura M, Kato T, Munemoto Y, Nakamura F, Bando H, Taniguchi H, Sakamoto Y, Shiozawa M, Nishi M, Horiuchi T, Yamagishi H, Sakamoto J, Mizushima T, Ohtsu A, Mori M. Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients With Stage III Colon Cancer: The Randomized Phase III ACHIEVE Trial. J Clin Oncol. 2022 Oct 10;40(29):3419-3429. doi: 10.1200/JCO.21.02628. Epub 2022 May 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2016-003729-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-915
Identifier Type: -
Identifier Source: org_study_id
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