MelanomaPhase 3CheckMate 915NCT03068455
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
A Phase 3 study testing nivolumab and ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 124 sites in 19 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- nivolumab and ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,844 participants
- Where
- 124 sitesin 19 countries
- Study dates
- 11 Apr 2017to 2 Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
124 sites in 19 countries.
124 sites in 19 countries
United States33 sites
University Of Michigan Health System
Ann Arbor, Michigan, 48109-5848
Winship Cancer Institute
Atlanta, Georgia, 30322
University Of Colorado
Aurora, Colorado, 80045
Mass General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Carolinas Med Ctr
Charlotte, North Carolina, 28204
University Of Virginia Health System
Charlottesville, Virginia, 22908
University Of Chicago
Chicago, Illinois, 19123
Northwestern University
Chicago, Illinois, 60611
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
St. Luke's University Health Network
Easton, Pennsylvania, 18045
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, 55905
Md Anderson Can Cnt
Houston, Texas, 77030-4009
The Angeles Clinic & Research Institute
Los Angeles, California, 90025
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Local Institution
Nashville, Tennessee, 37232
NYU Langone Medical Center
New York, New York, 10016
Memorial Sloan Kettering Nassau
New York, New York, 10065
UF Health Cancer Center at Orlando Health
Orlando, Florida, 32806
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068
Providence Cancer Center Oncology And Hematology Care
Portland, Oregon, 97213
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
California Pacific Medical Center
San Francisco, California, 94115
University Of Washington Cancer Care Alliance
Seattle, Washington, 98109-1023
Washington University School Of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
University of Arizona Cancer Center
Tucson, Arizona, 85724
Georgetown University Med Ctr
Washington D.C., District of Columbia, 20007
Australia12 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Box Hill, Victoria, 3128
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Melbourne, Victoria, 3000
Local Institution
Melbourne, Victoria, 3004
Local Institution
Nedlands, Western Australia, 6009
Local Institution
North Sydney, New South Wales, 2060
Local Institution
Southport, Queensland, 4215
Local Institution
Subiaco, Western Australia, 6008
Local Institution
Waratah, New South Wales, 2298
Local Institution
Westmead, New South Wales, 2145
Local Institution
Woolloongabba, Queensland, 4120
Brazil10 sites
Local Institution
Barretos, São Paulo, 14780-070
Local Institution
Belo Horizonte, Minas Gerais, 30130-090
Local Institution
Florianópolis, Santa Catarina, 88034-000
Local Institution
Ijuí, Rio Grande do Sul, 98700-000
Local Institution
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution
Rio de Janeiro, 20220-410
Local Institution
Rio de Janeiro, 22793-080
Local Institution
Salvador, Estado de Bahia, 41950-610
Local Institution
São José do Rio Preto, São Paulo, 15090-000
Local Institution
São Paulo, 01246-000
Germany9 sites
Local Institution
Berlin, 10117
Local Institution
Buxtehude, 21614
Local Institution
Essen, 45147
Local Institution
Gera, 07548
Local Institution
Hanover, 30625
Local Institution
Heidelberg, 69120
Local Institution
Lübeck, 23538
Local Institution
München, 80337
Local Institution
Tübingen, 72076
France8 sites
Centre Hospitalier Universitaire Dijon Bocage
Dijon, 21079
Hopital Claude Huriez
Lille, 59037
Hopital De La Timone
Marseille, 13385
Chu Nantes
Nantes, 44093
Hopital Saint Louis
Paris, 75475
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Institut Claudius Regaud
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
Canada7 sites
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Montreal, Quebec, H2L 4M1
Local Institution
Montreal, Quebec, H3T 1E2
Local Institution
Ottawa, Ontario, K1H 8L6
CHU de Quebec - Universite Laval
Québec, Quebec, G1R 2J6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Local Institution
Vancouver, British Columbia, V5Z 4E6
Spain7 sites
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona, 08916
H. Univ. Vall dHebron
Barcelona, 08035
Hospital Clinic I Provincial
Barcelona, 08036
Hospital Gral. Univ. Gregorio Maranon
Madrid, 28007
Hospital Regional Universitario De Malaga
Málaga, 29010
Hosp Univ Virgen Macarena
Seville, 41009
Hospital Universitario Y Politecnico La Fe
Valencia, 46026
Italy6 sites
ASST Papa Giovanni XXIII
Bergamo, 24127
Ospedale Policlinico San Martino
Genova, 16132
IRCCS Istituto Nazionale Tumori Milano
Milan, 20133
Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131
Istituto Oncologico Veneto IOV
Padova, 35128
Azienda Ospedaliera Universitaria Senese
Siena, 53100
United Kingdom5 sites
The Beatson West Of Scotland Cancer Centre
Glasgow, G12 0YN
The Royal Marsden Hospital
London, SW3 6JJ
Christie Hospital Nhs Trust
Manchester, M20 4BX
Local Institution
Oxford, Oxfordshire, OX3 7LJ
Royal Marsden Hospital - Surrey
Sutton, SM25PT
Belgium4 sites
Local Institution
Brussels, 1090
Local Institution
Brussels, 1200
Local Institution
Ghent, B-9000
Local Institution
Liège, 4000
Czechia4 sites
Klinika komplexni onkologicke pece
Brno, 656 53
Klinika onkologie a radioterapie
Hradec Králové, 500 05
Dermatovenerologicka klinika 3. LF UK a FNKV
Prague, 100 34
Dermatovenerologicka klinika VFN a 1. LF UK
Prague, 128 08
Israel3 sites
Local Institution
Haifa, 3109601
Local Institution
Jerusalem, 91120
Local Institution
Tel HaShomer, 52621
New Zealand3 sites
Local Institution
Christchurch
Local Institution
Dunedin, 9001
Local Institution
Tauranga, Bay of Plenty, 3143
Russia3 sites
Local Institution
Krasnodar, 350040
Local Institution
Krasnoyarsk, 660133
Local Institution
Moscow, 115478
Poland2 sites
Klinika Nowotworow Ukladowych i Uogolnionych
Krakow, 31-115
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781
Romania2 sites
Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
Bucharest, 022328
Sf. Nectarie Oncology Center
Craiova, 200347
Switzerland2 sites
Local Institution
Lausanne, 1011
Local Institution
Zurich, 8091
About this study
Official title: 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
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
- Conditions
- Melanoma
- Being tested
- nivolumab, ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabBiological
Also called Opdivo, BMS-936558
Specified Dose on Specified Days
ipilimumabBiological
Also called Yervoy, BMS-734016
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| nivolumab + ipilimumab | Experimental | Specified Dose on Specified Days Receives: Biological: nivolumab; Biological: ipilimumab |
| nivolumab | Experimental | Specified Dose on Specified Days Receives: Biological: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From randomization to Primary Completion Date (up to approximately 3 years)
Secondary outcomes (9)
Overall Survival (OS) - All Randomized Participants
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Measured: From randomization to date of death (up to approximately 45 months)
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Measured: From randomization to date of death (up to approximately 45 months)
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
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.
Measured: From randomization to Study Completion Date (up to approximately 45 months)
Time to Next-Line Therapies - All Randomized Participants
Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date.
Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date.
Measured: 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%
Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date.
Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date
Measured: From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Time From Next Therapy to Second Next Therapy - All Randomized Participants
Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
Measured: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
Measured: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
Measured: From randomization to progression event (up to approximately 45 months)
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
Measured: From randomization to progression event (up to approximately 45 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start11 Apr 2017
- Primary completion12 Jun 2020
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,844 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068455
- Sponsor's protocol ID
- CA209-915
- Other IDs
- 2016-003729-41, 2016
- Acronym
- CheckMate 915
- Status last verified
- Aug 2021
- First submitted
- 27 Feb 2017
- Last updated
- 20 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40645660Weber 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.
PubMed 36162037Yoshino 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.
PubMed 35512259
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03068455
- Acronym / sponsor ID
- CheckMate 915 / CA209-915
- Conditions
- Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,844 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 22 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nivolumab + ipilimumab | Experimental | Biological: nivolumab, Biological: ipilimumabSpecified Dose on Specified Days |
| nivolumab | Experimental | Biological: nivolumabSpecified Dose on Specified Days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nivolumabAlso: Opdivo, BMS-936558Specified Dose on Specified Days | Biological | nivolumab, nivolumab + ipilimumab |
| ipilimumabAlso: Yervoy, BMS-734016Specified Dose on Specified Days | Biological | nivolumab + ipilimumab |
Primary outcome
Recurrence-free Survival (RFS) - All Randomized Participants
Time frame: From randomization to Primary Completion Date (up to approximately 3 years)
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.
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
Time frame: From randomization to Primary Completion Date (up to approximately 3 years)
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.
9 secondary outcomes
Overall Survival (OS) - All Randomized Participants
Time frame: From randomization to date of death (up to approximately 45 months)
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
Time frame: From randomization to date of death (up to approximately 45 months)
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
Time frame: From randomization to Study Completion Date (up to approximately 45 months)
Time to Next-Line Therapies - All Randomized Participants
Time frame: 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%
Time frame: From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Time From Next Therapy to Second Next Therapy - All Randomized Participants
Time frame: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Time frame: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
Time frame: From randomization to progression event (up to approximately 45 months)
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Time frame: From randomization to progression event (up to approximately 45 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40645660Long 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.
- Derived from this study: PubMed 36162037Weber 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.
- Derived from this study: PubMed 35512259Yoshino 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
124 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nivolumab and ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 124 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 124 sites in United States, Australia, Brazil, Germany, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (RFS) - All Randomized Participants (time frame: From randomization to Primary Completion Date (up to approximately 3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068455, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.