Melanoma Clinical Trial

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

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Summary

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

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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.

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Eligibility Criteria

Inclusion Criteria:

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.

Study is for people with:

Melanoma

Estimated Enrollment:

160

Study ID:

NCT00928031

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 11 Locations for this study

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Arizona Cancer Center
Tuscon Arizona, 85724, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
USC Norris Cancer Center
Los Angeles California, 90033, United States
University of Miami Sylvester Cancer Center
Miami Florida, 33136, United States
St. Francis Research Foundation
Beech Grove Indiana, 46107, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
NYU Cancer Institute
New York New York, 10016, United States
Carolinas Cancer Care
Charlotte North Carolina, 28211, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
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How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

160

Study ID:

NCT00928031

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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