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)