A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide

Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma

The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.

Inclusion Criteria:

• Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
• Flexible Sigmoidoscopy and colonic biopsy required

Exclusion Criteria:

• Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.