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

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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)