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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)

Trial Status: Closed to Accrual

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

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)

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: COMPLETED

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

New York

Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-037
  • Secondary IDs NCI-2013-00289, 2012-001828-35, s12-02400
  • Clinicaltrials.gov ID NCT01721746