Clinical trial NCT03068455: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 1844
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence-free Survival (RFS) - All Randomized Participants
timeFrame: From randomization to Primary Completion Date (up to approximately 3 years)
measure: Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
timeFrame: From randomization to Primary Completion Date (up to approximately 3 years)
Secondary outcomes:
measure: Overall Survival (OS) - All Randomized Participants
timeFrame: From randomization to date of death (up to approximately 45 months)
measure: Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
timeFrame: From randomization to date of death (up to approximately 45 months)
measure: Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
timeFrame: From randomization to Study Completion Date (up to approximately 45 months)
measure: Time to Next-Line Therapies - All Randomized Participants
timeFrame: From randomization to start of next therapy or second next therapy (up to approximately 45 months)
measure: Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
timeFrame: From randomization to start of next therapy or second next therapy (up to approximately 45 months)
measure: Time From Next Therapy to Second Next Therapy - All Randomized Participants
timeFrame: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
measure: Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
timeFrame: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
measure: Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
timeFrame: From randomization to progression event (up to approximately 45 months)
measure: Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
timeFrame: From randomization to progression event (up to approximately 45 months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: The Angeles Clinic & Research Institute
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Washington
country: United States
facility: Georgetown University Med Ctr
state: District of Columbia
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Charlotte
country: United States
facility: Carolinas Med Ctr
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Providence Cancer Center Oncology And Hematology Care
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Easton
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Md Anderson Can Cnt
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: Inova Melanoma and Skin Cancer Center
state: Virginia
city: Seattle
country: United States
facility: University Of Washington Cancer Care Alliance
state: Washington
city: North Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Southport
country: Australia
facility: Local Institution
state: Queensland
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Subiaco
country: Australia
facility: Local Institution
state: Western Australia
city: Graz
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Ijui
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Florianópolis
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Universite Laval
city: Brno
country: Czechia
facility: Klinika komplexni onkologicke pece
city: Hradec Kralove
country: Czechia
facility: Klinika onkologie a radioterapie
city: Praha 10
country: Czechia
facility: Dermatovenerologicka klinika 3. LF UK a FNKV
city: Praha 2
country: Czechia
facility: Dermatovenerologicka klinika VFN a 1. LF UK
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bocage
city: LILLE Cedex
country: France
facility: Hopital Claude Huriez
city: Marseille Cedex 5
country: France
facility: Hopital De La Timone
city: Nantes
country: France
facility: Chu Nantes
city: Paris
country: France
facility: Hopital Saint Louis
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Local Institution
city: Buxtehude
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Gera
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Luebeck
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Tuebingen
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Laiko Hospital
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Tel Hashomer
country: Israel
facility: Local Institution
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: IRCCS Istituto Nazionale Tumori Milano
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Tauranga
country: New Zealand
facility: Local Institution
state: BAY OF Plenty
city: Christchurch
country: New Zealand
facility: Local Institution
city: Dunedin
country: New Zealand
facility: Local Institution
city: Krakow
country: Poland
facility: Klinika Nowotworow Ukladowych i Uogolnionych
city: Warszawa
country: Poland
facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
city: Bucharest
country: Romania
facility: Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
city: Craiova
country: Romania
facility: Sf. Nectarie Oncology Center
city: Krasnodar
country: Russian Federation
facility: Local Institution
city: Krasnoyarsk
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Badalona-barcelona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Barcelona
country: Spain
facility: H. Univ. Vall dHebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Gral. Univ. Gregorio Maranon
city: Malaga
country: Spain
facility: Hospital Regional Universitario De Malaga
city: Sevilla
country: Spain
facility: Hosp Univ Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnico La Fe
city: Lausanne
country: Switzerland
facility: Local Institution
city: Zuerich
country: Switzerland
facility: Local Institution
city: Oxford
country: United Kingdom
facility: Local Institution
state: Oxfordshire
city: Glasgow
country: United Kingdom
facility: The Beatson West Of Scotland Cancer Centre
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust
city: Sutton.
country: United Kingdom
facility: Royal Marsden Hospital - Surrey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.