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

Metastatic Melanoma Clinical Trial

— MDX010-28  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928031
• Other study ID #: MDX010-28
• Status: Completed
• Phase: N/A
• First received: June 24, 2009
• Last updated: April 23, 2010
• Start date: June 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Metastatic Melanoma

Locations

Country	Name	City	State
United States	St. Francis Research Foundation	Beech Grove	Indiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Carolinas Cancer Care	Charlotte	North Carolina
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	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	Arizona Cancer Center	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm