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Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

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ClinicalTrials.gov Identifier: NCT00495066
Expanded Access Status : No longer available
First Posted : July 2, 2007
Last Update Posted : June 3, 2013
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date June 29, 2007
First Posted Date July 2, 2007
Last Update Posted Date June 3, 2013
Descriptive Information
Brief Title Compassionate Use Trial for Unresectable Melanoma With Ipilimumab
Brief Summary The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3 mg/kg induction (with re-induction, if eligible), or for eligible subjects previously enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: Ipilimumab
Intravenous Solution, Intravenous, Ipilimumab 3 mg/kg, Ipilimumab - one dose every 3 wks for a total of 4 doses. Subjects who are eligible may receive another 4 doses given every 3 wks; Until disease progression, unacceptable toxicity or withdrawal of consent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries Argentina,   Canada,   Puerto Rico,   United States
Administrative Information
NCT Number NCT00495066
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Not Provided
Current Study Sponsor Bristol-Myers Squibb
Original Study Sponsor Same as current
Collaborators Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2013