MDX010-28: Long-term Data Collection for Subjects in MDX-010 Studies
Study Details
Study Description
Brief Summary
The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15.
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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.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Arizona Cancer Center | Tuscon | Arizona | United States | 85724 |
2 | Pacific Shores Medical Group | Long Beach | California | United States | 90813 |
3 | The Angeles Clinic and Research Institute | Los Angeles | California | United States | 90025 |
4 | USC Norris Cancer Center | Los Angeles | California | United States | 90033 |
5 | University of Miami Sylvester Cancer Center | Miami | Florida | United States | 33136 |
6 | St. Francis Research Foundation | Beech Grove | Indiana | United States | 46107 |
7 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
8 | NYU Cancer Institute | New York | New York | United States | 10016 |
9 | Carolinas Cancer Care | Charlotte | North Carolina | United States | 28211 |
10 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
11 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Principal Investigator: Walter Urba, MD PhD, Providence Health & Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDX010-28