Long-term Data Collection for Subjects in MDX-010 Studies (MDX010-28)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Metastatic Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT00928031

MDX010-28

Details and patient eligibility

About

The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.