Status:
COMPLETED
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Medarex
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 investigati...
Detailed Description
For the extension phase: Allocation: single arm study; Masking: open label; Intervention Model: Single Group
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
681 Patients enrolled
Trial Details
Trial ID
NCT00324155
Start Date
August 1 2006
End Date
October 1 2013
Last Update
November 3 2014
Active Locations (127)
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1
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
2
Wilshire Oncology Medical Group Inc
La Verne, California, United States, 91750
3
The Angeles Clinic And Research Institute
Los Angeles, California, United States, 90025
4
Comprehensive Cancer Center
Palm Springs, California, United States, 92262