Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable or Metastatic Melanoma (CheckMate 218)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) 2010 staging system, including mucosal melanoma
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
• Anti-CTLA-4 treatment-naïve patients who may have had other prior systemic treatment for localized or metastatic disease. Note that prior systemic therapy is permitted if it was completed at least 4 weeks prior to first dose, and all related adverse events have either returned to baseline or stabilized
• Primary mucosal melanoma is allowed
• Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
• Men and women, aged 18 years

Exclusion Criteria:

• Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
• Life expectancy < 6 weeks
• Subjects diagnosed with primary ocular melanoma
• Subjects with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
• Prior treatment in any Nivolumab or Ipilimumab clinical study (including those who have been randomized to control)
• Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
• Known history of testing positive for Human immunodeficiency virus (HIV) or known Acquired immunodeficiency syndrome (AIDS)