Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

Phase 2

Completed

• Conditions: Melanoma

• Registration Number: NCT00050102
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine \[DTIC\]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2002-11-21
• Study First Submitted QC: 2002-11-21
• Study First Posted: 2002-11-22
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2011-01
• Disposition First Submitted: 2011-01-12
• Disposition First Submitted QC: 2011-01-20
• Last Update Submitted: 2011-01-20
• Disposition First Posted: 2011-01-28
• Last Update Posted: 2011-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (9)

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

Cancer Institute Medical Group; 🇺🇸 Santa Monica, California, United States

Indiana Oncology/ Hematology Consultants; 🇺🇸 Indianapolis, Indiana, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Joe Arrington Cancer. Research & Treatment Center; 🇺🇸 Lubbock, Texas, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Northern California Melanoma Center; 🇺🇸 San Francisco, California, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Piedmont Oncology Specialists; 🇺🇸 Charlotte, North Carolina, United States