Trial Information

Summary: Phase II Study in Patients With Untreated Unresectable Stage II or IV Melanoma Receiving Dacarbazine and Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), known as ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called dacarbazine.

Inclusion Criteria

• Informed Consent
• Measurable Disease
• ECOG 0 or 1
• Lab/Imaging Requirements
• Neg for HIV, HepB, C
• Men and Women > 18 years (16 were allowable)
• Prior Therapy Restriction (Adjuvant Only)

Exclusion Criteria

• Pregnant/Nursing
• Inadequate Contraception
• Brain Metastasis
• Primary Ocular or Mucosal Melanoma

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Trial listings updated: June 1, 2008 at 6:30:16 AM