Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma

The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable

Inclusion Criteria:

• Histologically or cytologically confirmed malignant melanoma
• Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
• Willing to undergo up to 3 biopsies of an accessible lesion

Exclusion Criteria:

• Active/symptomatic brain metastases
• Primary ocular melanoma or primary tumor of unknown origin
• Concurrent autoimmune disease
• Previous treatment with a CD137 agonist or CTLA-4 inhibitor