Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Principal Investigator
Walter Urba, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Providence Health & Services
Authority:
United States: Food and Drug Administration
Study ID:
MDX010-28
NCT ID:
NCT00928031
Start Date:
June 2007
Completion Date:
April 2009
Related Keywords:
- Metastatic Melanoma
- Melanoma
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Pacific Shores Medical Group | Long Beach, California 90813 |
| University of Miami Sylvester Cancer Center | Miami, Florida 33136 |
| NYU Cancer Institute | New York, New York 10016 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| USC Norris Cancer Center | Los Angeles, California 90033 |
| The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
| St. Francis Research Foundation | Beech Grove, Indiana 46107 |
| Carolinas Cancer Care | Charlotte, North Carolina 28211 |
