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 |
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
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
660 S Euclid Ave
Saint Louis, Missouri 63110
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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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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