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

Status: Recruiting
Phase: Phase 3
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01721746 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

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

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Donald Lawrence, MD, Massachusetts General Hospital
David McDermott, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Suzanne MacRae, 617-632-5906, smacrae@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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 - RECIST defined disease progression during or after ≤ 2 prior treatment regimens - Pre-treatment fresh core or excision tumor biopsy. - Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available Exclusion Criteria: - Any treatment in a BMS-936558 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)
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