A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:December 13, 2012
End Date:March 6, 2019

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A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

The purpose of the study is to estimate the response rate and compare overall survival of
patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or
Carboplatin and Paclitaxel


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Men & women ≥ 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

- Histologically confirmed Stage III (unresectable)/Stage IV melanoma

- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- Objective evidence of disease progression (clinical or radiological) during or after
at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment
regimens

- Pre-treatment fresh core, excision or punch tumor biopsy

- Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

Exclusion Criteria:

- Any treatment in a BMS-936558 (Nivolumab) trial

- Subjects with condition requiring systemic treatment with either corticosteroids (>
10mg daily prednisone/equivalent) or other immunosuppressive medications within 14
days of study drug administration

- Active, known or suspected autoimmune disease

- Unknown BRAF status

- Active brain metastasis or leptomeningeal metastasis

- Ocular melanoma

- Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1
(anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
We found this trial at
31
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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24 Sturtevant St
Orlando, Florida 32806
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Allentown, Pennsylvania 18103
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30322
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Aurora, Colorado 80045
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlotte, North Carolina 28211
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Cleveland, Ohio 44106
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Detroit, Michigan 48201
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1872 Saint Luke's Boulevard
Easton, Pennsylvania 18045
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Innsbruck,
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La Jolla, California 92093
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Los Angeles, California 90025
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Miami Beach, Florida 33140
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Minneapolis, Minnesota 55407
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10016
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Pittsburgh, Pennsylvania 15232
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Portland, Oregon 97213
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
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San Francisco, California 94115
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San Francisco, California 94115
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Scottsdale, Arizona 85259
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