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

Melanoma Clinical Trial

Official title:
A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

Clinical Trial 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

Clinical Trial Description

For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00324155
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 3
Start date August 2006
Completion date October 2013
View Details
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