Long-term Data Collection for Subjects in MDX-010 Studies (MDX010-28)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00928031
First received: June 24, 2009
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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


Condition
Metastatic Melanoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Enrollment: 160
Study Start Date: June 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928031

Locations
United States, Arizona
Arizona Cancer Center
Tuscon, Arizona, United States, 85724
United States, California
Pacific Shores Medical Group
Long Beach, California, United States, 90813
USC Norris Cancer Center
Los Angeles, California, United States, 90033
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
United States, Florida
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Indiana
St. Francis Research Foundation
Beech Grove, Indiana, United States, 46107
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
United States, North Carolina
Carolinas Cancer Care
Charlotte, North Carolina, United States, 28211
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Utah
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
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00928031     History of Changes
Other Study ID Numbers: MDX010-28
Study First Received: June 24, 2009
Last Updated: April 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 22, 2014