Long-term Data Collection for Subjects in MDX-010 Studies
- Conditions
- Metastatic Melanoma
- Registration Number
- NCT00928031
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.
- Detailed Description
This is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies MDX010-02, MDX010-08, and MDX010-15. The purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15.
- Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
- For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Arizona Cancer Center
🇺🇸Tuscon, Arizona, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
USC Norris Cancer Center
🇺🇸Los Angeles, California, United States
University of Miami Sylvester Cancer Center
🇺🇸Miami, Florida, United States
St. Francis Research Foundation
🇺🇸Beech Grove, Indiana, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
NYU Cancer Institute
🇺🇸New York, New York, United States
Carolinas Cancer Care
🇺🇸Charlotte, North Carolina, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Scroll for more (1 remaining)Arizona Cancer Center🇺🇸Tuscon, Arizona, United States