A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.

Inclusion Criteria

Inclusion Criteria

- Clinical diagnosis of unresectable metastatic melanoma.

- No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within
5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy)
for melanoma.

Exclusion Criteria

Patients who exhibit any of the following conditions at screening will not be eligible for
admission into the study:

- Any other prior malignancy, except for the following: adequately treated basal or
squamous cell skin cancer or superficial bladder cancer, or any other cancer from
which the patient has been disease-free for >=5 years.

- Active autoimmune disease.

- Active infection requiring therapy, or chronic active HBV or HCV, or confirmed
reactivity with HIV tests.