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

Melanoma Clinical Trial

— CheckMate 915  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068455
• Other study ID #: CA209-915
• Secondary ID: 2016-003729-41
• Status: Completed
• Phase: Phase 3
• Start date: April 11, 2017
• Est. completion date: February 2, 2021

Study information

• Verified date: August 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1844
• Est. completion date: February 2, 2021
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• nivolumab
Specified Dose on Specified Days
• ipilimumab
Specified Dose on Specified Days

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Box Hill	Victoria
Australia	Local Institution	Greenslopes	Queensland
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Nedlands	Western Australia
Australia	Local Institution	North Sydney	New South Wales
Australia	Local Institution	Southport	Queensland
Australia	Local Institution	Subiaco	Western Australia
Australia	Local Institution	Waratah	New South Wales
Australia	Local Institution	Westmead	New South Wales
Australia	Local Institution	Woolloongabba	Queensland
Austria	Local Institution	Graz
Austria	Local Institution	Wien
Belgium	Local Institution	Brussels
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Gent
Belgium	Local Institution	Liege
Brazil	Local Institution	Barretos	Sao Paulo
Brazil	Local Institution	Belo Horizonte	Minas Gerais
Brazil	Local Institution	Florianópolis	Santa Catarina
Brazil	Local Institution	Ijui	RIO Grande DO SUL
Brazil	Local Institution	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Rio de Janeiro
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Sao Jose do Rio Preto	SAO Paulo
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Ottawa	Ontario
Canada	CHU de Quebec - Universite Laval	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Czechia	Klinika komplexni onkologicke pece	Brno
Czechia	Klinika onkologie a radioterapie	Hradec Kralove
Czechia	Dermatovenerologicka klinika 3. LF UK a FNKV	Praha 10
Czechia	Dermatovenerologicka klinika VFN a 1. LF UK	Praha 2
France	Centre Hospitalier Universitaire Dijon Bocage	Dijon
France	Hopital Claude Huriez	LILLE Cedex
France	Hopital De La Timone	Marseille Cedex 5
France	Chu Nantes	Nantes
France	Hopital Saint Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite Cedex
France	Institut Claudius Regaud	Toulouse Cedex 9
France	Institut Gustave Roussy	Villejuif
Germany	Local Institution	Berlin
Germany	Local Institution	Buxtehude
Germany	Local Institution	Essen
Germany	Local Institution	Gera
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Germany	Local Institution	Luebeck
Germany	Local Institution	Muenchen
Germany	Local Institution	Tuebingen
Greece	Laiko Hospital	Athens
Greece	Metropolitan Hospital	Athens
Israel	Local Institution	Haifa
Israel	Local Institution	Jerusalem
Israel	Local Institution	Tel Hashomer
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	Ospedale Policlinico San Martino	Genova
Italy	IRCCS Istituto Nazionale Tumori Milano	Milano
Italy	Istituto Nazionale Tumori Fondazione Pascale	Napoli
Italy	Istituto Oncologico Veneto IOV	Padova
Italy	Azienda Ospedaliera Universitaria Senese	Siena
New Zealand	Local Institution	Christchurch
New Zealand	Local Institution	Dunedin
New Zealand	Local Institution	Tauranga	BAY OF Plenty
Poland	Klinika Nowotworow Ukladowych i Uogolnionych	Krakow
Poland	Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow	Warszawa
Romania	Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha	Bucharest
Romania	Sf. Nectarie Oncology Center	Craiova
Russian Federation	Local Institution	Krasnodar
Russian Federation	Local Institution	Krasnoyarsk
Russian Federation	Local Institution	Moscow
Spain	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	Malaga
Spain	Hosp Univ Virgen Macarena	Sevilla
Spain	Hospital Universitario Y Politecnico La Fe	Valencia
Switzerland	Local Institution	Lausanne
Switzerland	Local Institution	Zuerich
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	Local Institution	Oxford	Oxfordshire
United Kingdom	Royal Marsden Hospital - Surrey	Sutton.
United States	University Of Michigan Health System	Ann Arbor	Michigan
United States	Winship Cancer Institute	Atlanta	Georgia
United States	University Of Colorado	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Mass General Hospital	Boston	Massachusetts
United States	Carolinas Med Ctr	Charlotte	North Carolina
United States	University Of Virginia Health System	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	University Of Chicago	Chicago	Illinois
United States	Texas Oncology Sammons Cancer Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Luke's University Health Network	Easton	Pennsylvania
United States	Inova Melanoma and Skin Cancer Center	Fairfax	Virginia
United States	Md Anderson Can Cnt	Houston	Texas
United States	The Angeles Clinic & Research Institute	Los Angeles	California
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Local Institution	Nashville	Tennessee
United States	Memorial Sloan Kettering Nassau	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	UF Health Cancer Center at Orlando Health	Orlando	Florida
United States	Oncology Specialists, S.C.	Park Ridge	Illinois
United States	Oregon Health & Science University	Portland	Oregon
United States	Providence Cancer Center Oncology And Hematology Care	Portland	Oregon
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	California Pacific Medical Center	San Francisco	California
United States	University Of Washington Cancer Care Alliance	Seattle	Washington
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	Georgetown University Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Greece,  Israel,  Italy,  New Zealand,  Poland,  Romania,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	From randomization to date of death (up to approximately 45 months)
Secondary	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.	From randomization to date of death (up to approximately 45 months)
Secondary	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.	From randomization to Study Completion Date (up to approximately 45 months)
Secondary	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.	From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Secondary	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	From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Secondary	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.	From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Secondary	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.	From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Secondary	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.	From randomization to progression event (up to approximately 45 months)
Secondary	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.	From randomization to progression event (up to approximately 45 months)

External Links

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