Melanoma Clinical Trial

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

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

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1844

Study ID:

NCT03068455

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 119 Locations for this study

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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 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, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Washington University School Of Medicine
Saint 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, 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, United States
Local Institution
North Sydney New South Wales, 2060, Australia
Local Institution
Waratah New South Wales, 2298, Australia
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Westmead New South Wales, 2145, Australia
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Greenslopes Queensland, 4120, Australia
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Southport Queensland, 4215, Australia
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Woolloongabba Queensland, 4120, Australia
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Adelaide South Australia, 5000, Australia
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Box Hill Victoria, 3128, Australia
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Melbourne Victoria, 3000, Australia
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Melbourne Victoria, 3004, Australia
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Nedlands Western Australia, 6009, Australia
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Subiaco Western Australia, 6008, Australia
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Graz , 8036, Austria
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Wien , 1090, Austria
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Brussels , 1090, Belgium
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Bruxelles , 1200, Belgium
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Gent , B-900, Belgium
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Liege , 4000, Belgium
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Salvador Bahia, 41950, Brazil
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Belo Horizonte Minas Gerais, 30130, Brazil
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Ijui RIO Grande DO SUL, 98700, Brazil
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Porto Alegre RIO Grande DO SUL, 90610, Brazil
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Florianópolis Santa Catarina, 88034, Brazil
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Barretos Sao Paulo, 14780, Brazil
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Sao Jose do Rio Preto SAO Paulo, 15090, Brazil
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Rio De Janeiro , 20220, Brazil
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Rio de Janeiro , 22793, Brazil
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Sao Paulo , 01246, Brazil
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Edmonton Alberta, T6G 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H2L 4, Canada
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Montreal Quebec, H3T 1, Canada
CHU de Quebec - Universite Laval
Quebec , G1R 2, Canada
Klinika komplexni onkologicke pece
Brno , 656 5, Czechia
Klinika onkologie a radioterapie
Hradec Kralove , 500 0, Czechia
Dermatovenerologicka klinika 3. LF UK a FNKV
Praha 10 , 100 3, Czechia
Dermatovenerologicka klinika VFN a 1. LF UK
Praha 2 , 128 0, Czechia
Centre Hospitalier Universitaire Dijon Bocage
Dijon , 21079, France
Hopital Claude Huriez
LILLE Cedex , 59037, France
Hopital De La Timone
Marseille Cedex 5 , 13385, France
Chu Nantes
Nantes , 44093, France
Hopital Saint Louis
Paris , 75475, France
Centre Hospitalier Lyon Sud
Pierre Benite Cedex , 69495, France
Institut Claudius Regaud
Toulouse Cedex 9 , 31059, France
Institut Gustave Roussy
Villejuif , 94805, France
Local Institution
Berlin , 10117, Germany
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Buxtehude , 21614, Germany
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Essen , 45147, Germany
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Gera , 07548, Germany
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Hannover , 30625, Germany
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Heidelberg , 69120, Germany
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Luebeck , 23538, Germany
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Muenchen , 80337, Germany
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Tuebingen , 72076, Germany
Laiko Hospital
Athens , 11527, Greece
Metropolitan Hospital
Athens , 18547, Greece
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Haifa , 31096, Israel
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Jerusalem , 91120, Israel
Local Institution
Tel Hashomer , 52621, Israel
ASST Papa Giovanni XXIII
Bergamo , 24127, Italy
Ospedale Policlinico San Martino
Genova , 16132, Italy
IRCCS Istituto Nazionale Tumori Milano
Milano , 20133, Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli , 80131, Italy
Istituto Oncologico Veneto IOV
Padova , 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 , 31-11, Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warszawa , 02-78, Poland
Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
Bucharest , 02232, Romania
Sf. Nectarie Oncology Center
Craiova , 20034, Romania
Local Institution
Krasnodar , 35004, Russian Federation
Local Institution
Krasnoyarsk , 66013, Russian Federation
Local Institution
Moscow , 11547, Russian Federation
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
Malaga , 29010, Spain
Hosp Univ Virgen Macarena
Sevilla , 41009, Spain
Hospital Universitario Y Politecnico La Fe
Valencia , 46026, Spain
Local Institution
Lausanne , 1011, Switzerland
Local Institution
Zuerich , 8091, Switzerland
Local Institution
Oxford Oxfordshire, OX3 7, United Kingdom
The Beatson West Of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
The Royal Marsden Hospital
London , SW3 6, United Kingdom
Christie Hospital Nhs Trust
Manchester , M20 4, United Kingdom
Royal Marsden Hospital - Surrey
Sutton. , SM25P, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1844

Study ID:

NCT03068455

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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