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
CheckMate 915
A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
2 other identifiers
interventional
1,844
18 countries
122
Brief Summary
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2017
Typical duration for phase_3
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedStudy Start
First participant enrolled
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2021
CompletedResults Posted
Study results publicly available
July 22, 2021
CompletedSeptember 20, 2021
August 1, 2021
3.2 years
February 27, 2017
June 8, 2021
August 24, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Recurrence-free Survival (RFS) - All Randomized Participants
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median values based on Kaplan-Meier Estimates.
From randomization to Primary Completion Date (up to approximately 3 years)
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median based on Kaplan-Meier Estimates.
From randomization to Primary Completion Date (up to approximately 3 years)
Secondary Outcomes (9)
Overall Survival (OS) - All Randomized Participants
From randomization to date of death (up to approximately 45 months)
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
From randomization to date of death (up to approximately 45 months)
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
From randomization to Study Completion Date (up to approximately 45 months)
Time to Next-Line Therapies - All Randomized Participants
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
- +4 more secondary outcomes
Study Arms (2)
nivolumab + ipilimumab
EXPERIMENTALSpecified Dose on Specified Days
nivolumab
EXPERIMENTALSpecified Dose on Specified Days
Interventions
Specified Dose on Specified Days
Specified Dose on Specified Days
Eligibility Criteria
You may qualify if:
- Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
- 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)
You may not qualify if:
- History of uveal melanoma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (124)
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
The Angeles Clinic & Research Institute
Los Angeles, California, 90025, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Georgetown University Med Ctr
Washington D.C., District of Columbia, 20007, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University Of Chicago
Chicago, Illinois, 19123, United States
Northwestern University
Chicago, Illinois, 60611, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University Of Michigan Health System
Ann Arbor, Michigan, 48109-5848, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Memorial Sloan Kettering Nassau
New York, New York, 10065, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Providence Cancer Center Oncology And Hematology Care
Portland, Oregon, 97213, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
St. Luke's University Health Network
Easton, Pennsylvania, 18045, United States
Local Institution
Nashville, Tennessee, 37232, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246, United States
Md Anderson Can Cnt
Houston, Texas, 77030-4009, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University Of Virginia Health System
Charlottesville, Virginia, 22908, United States
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, 55905, United States
University Of Washington Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
Local Institution
North Sydney, New South Wales, 2060, Australia
Local Institution
Waratah, New South Wales, 2298, Australia
Local Institution
Westmead, New South Wales, 2145, Australia
Local Institution
Greenslopes, Queensland, 4120, Australia
Local Institution
Southport, Queensland, 4215, Australia
Local Institution
Woolloongabba, Queensland, 4120, Australia
Local Institution
Adelaide, South Australia, 5000, Australia
Local Institution
Box Hill, Victoria, 3128, Australia
Local Institution
Melbourne, Victoria, 3000, Australia
Local Institution
Melbourne, Victoria, 3004, Australia
Local Institution
Nedlands, Western Australia, 6009, Australia
Local Institution
Subiaco, Western Australia, 6008, Australia
Local Institution
Graz, 8036, Austria
Local Institution
Vienna, 1090, Austria
Local Institution
Brussels, 1090, Belgium
Local Institution
Brussels, 1200, Belgium
Local Institution
Ghent, B-9000, Belgium
Local Institution
Liège, 4000, Belgium
Local Institution
Salvador, Estado de Bahia, 41950-610, Brazil
Local Institution
Belo Horizonte, Minas Gerais, 30130-090, Brazil
Local Institution
IjuÃ, Rio Grande do Sul, 98700-000, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Local Institution
Florianópolis, Santa Catarina, 88034-000, Brazil
Local Institution
Barretos, São Paulo, 14780-070, Brazil
Local Institution
São José do Rio Preto, São Paulo, 15090-000, Brazil
Local Institution
Rio de Janeiro, 20220-410, Brazil
Local Institution
Rio de Janeiro, 22793-080, Brazil
Local Institution
São Paulo, 01246-000, Brazil
Local Institution
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution
Vancouver, British Columbia, V5Z 4E6, Canada
Local Institution
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Local Institution
Montreal, Quebec, H2L 4M1, Canada
Local Institution
Montreal, Quebec, H3T 1E2, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, G1R 2J6, Canada
Klinika komplexni onkologicke pece
Brno, 656 53, Czechia
Klinika onkologie a radioterapie
Hradec Králové, 500 05, Czechia
Dermatovenerologicka klinika 3. LF UK a FNKV
Prague, 100 34, Czechia
Dermatovenerologicka klinika VFN a 1. LF UK
Prague, 128 08, Czechia
Centre Hospitalier Universitaire Dijon Bocage
Dijon, 21079, France
Hopital Claude Huriez
Lille, 59037, France
Hopital De La Timone
Marseille, 13385, France
Chu Nantes
Nantes, 44093, France
Hopital Saint Louis
Paris, 75475, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Local Institution
Berlin, 10117, Germany
Local Institution
Buxtehude, 21614, Germany
Local Institution
Essen, 45147, Germany
Local Institution
Gera, 07548, Germany
Local Institution
Hanover, 30625, Germany
Local Institution
Heidelberg, 69120, Germany
Local Institution
Lübeck, 23538, Germany
Local Institution
München, 80337, Germany
Local Institution
Tübingen, 72076, Germany
Laiko Hospital
Athens, 11527, Greece
Metropolitan Hospital
Athens, 18547, Greece
Local Institution
Haifa, 3109601, Israel
Local Institution
Jerusalem, 91120, Israel
Local Institution
Tel Litwinsky, 52621, Israel
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale Policlinico San Martino
Genova, 16132, Italy
IRCCS Istituto Nazionale Tumori Milano
Milan, 20133, Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, 80131, Italy
Istituto Oncologico Veneto IOV
Padua, 35128, Italy
Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
Local Institution
Tauranga, Bay of Plenty, 3143, New Zealand
Local Institution
Christchurch, New Zealand
Local Institution
Dunedin, 9001, New Zealand
Klinika Nowotworow Ukladowych i Uogolnionych
Krakow, 31-115, Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781, Poland
Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
Bucharest, 022328, Romania
Sf. Nectarie Oncology Center
Craiova, 200347, Romania
Local Institution
Krasnodar, 350040, Russia
Local Institution
Krasnoyarsk, 660133, Russia
Local Institution
Moscow, 115478, Russia
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona, 08916, Spain
H. Univ. Vall dHebron
Barcelona, 08035, Spain
Hospital Clinic I Provincial
Barcelona, 08036, Spain
Hospital Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hospital Regional Universitario De Malaga
Málaga, 29010, Spain
Hosp Univ Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Y Politecnico La Fe
Valencia, 46026, Spain
Local Institution
Lausanne, 1011, Switzerland
Local Institution
Zurich, 8091, Switzerland
Local Institution
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
The Beatson West Of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
The Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Christie Hospital Nhs Trust
Manchester, M20 4BX, United Kingdom
Royal Marsden Hospital - Surrey
Sutton, SM25PT, United Kingdom
Related Publications (3)
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.
PMID: 40645660DERIVEDWeber 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.
PMID: 36162037DERIVEDYoshino 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.
PMID: 35512259DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2017
First Posted
March 1, 2017
Study Start
April 11, 2017
Primary Completion
June 12, 2020
Study Completion
February 2, 2021
Last Updated
September 20, 2021
Results First Posted
July 22, 2021
Record last verified: 2021-08