Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma

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

Inclusion Criteria:

- Men and women 18 years and older

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Histologically-confirmed unresectable stage III or stage IV melanoma, as per American
Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular
melanoma

- Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects
may have had other prior systemic treatment for localized or metastatic disease

- 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
equivalent) for at least 2 weeks prior to study drug administration

Exclusion Criteria:

- Active (symptomatic) and not treated brain metastases or leptomeningeal metastases

- Life expectancy < 6 weeks

- Subjects with active, known, or suspected autoimmune disease. Subjects with Type I
diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders
(such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
conditions not expected to recur in absence of an external trigger are permitted to
enroll

- 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

- Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or
anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell
costimulation or checkpoint pathways) or subject is expected to require any other
form of systemic antineoplastic therapy while receiving nivolumab