Long-term Data Collection for Subjects in MDX-010 Studies

Completed

• 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-23
• Last Update Posted: 2010-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15.
2. 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.
3. 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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

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

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

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

St. Francis Research Foundation; 🇺🇸 Beech Grove, Indiana, United States

NYU Cancer Institute; 🇺🇸 New York, New York, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

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

Carolinas Cancer Care; 🇺🇸 Charlotte, North Carolina, United States

University of Miami Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States