Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma

Bristol-Myers Squibb11 sites in 1 country160 target enrollmentJune 2007

ConditionsMetastatic Melanoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 160
Locations: 11
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

April 2009

Last Updated

16 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

•Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-
•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.