Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Medarex
• Treatments: Antibodies, Monoclonal; Dacarbazine; Ipilimumab

Criteria

Inclusion Criteria:

• Informed Consent

• Measurable Disease

• Eastern Cooperative Oncology Group (ECOG) 0 or 1

• Lab / imaging requirements

• Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C

• Men and Women > 18 years (16 were allowable)

• Prior therapy restriction (adjuvant only)

Exclusion:

• Pregnant / nursing

• Inadequate contraception

• Brain metastasis

• Primary ocular or mucosal melanoma