An Open-Label, Randomized, Phase 2 Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma

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:

- Histologically confirmed unresectable Stage III or IV melanoma

- Treatment-naive or experienced disease recurrence or progression during or after one
prior systemic regimen for advanced disease

- Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Known BRAF V600 mutation status or consent to BRAF V600 mutation testing

- Sufficient tumor tissue accessible for baseline and post-treatment biopsies.

Exclusion Criteria:

- Active central nervous system (CNS) metastases

- Carcinomatous meningitis

- Active, known or suspected autoimmune disease

- Condition requiring systemic treatment with either corticosteroids (>10 mg daily
prednisone equivalent) or other immunosuppressive medications within 14 days of
randomization

- Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1
(PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4)
antibody

- Prior treatment with other immunotherapies

- Prior therapy with BRAF inhibitor