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
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Tracking Information | ||||
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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
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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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 | |||
Responsible Party | Bristol-Myers Squibb | |||
Study Sponsor | Bristol-Myers Squibb | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Bristol-Myers Squibb | |||
Verification Date | May 2013 |