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)

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)