Clinical trial NCT00928031: Long-term Data Collection for Subjects in MDX-010 Studies
Official title: Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received any dose of ipilimumab (MDX-010) in MDX010-02, MDX010-08, and MDX010-15 and were alive at the time of study completion.

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

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Miami
country: United States
facility: University of Miami Sylvester Cancer Center
state: Florida
city: Beech Grove
country: United States
facility: St. Francis Research Foundation
state: Indiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
city: Charlotte
country: United States
facility: Carolinas Cancer Care
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Providence Health & Services
name: Walter Urba, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: