Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

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 *	Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.; Kitano S, Postow MA, Ziegler CG, Kuk D, Panageas KS, Cortez C, Rasalan T, Adamow M, Yuan J, Wong P, Altan-Bonnet G, Wolchok JD, Lesokhin AM. Computational algorithm-driven evaluation of monocytic myeloid-derived suppressor cell frequency for prediction of clinical outcomes. Cancer Immunol Res. 2014 Aug;2(8):812-21. doi: 10.1158/2326-6066.CIR-14-0013. Epub 2014 May 20.; Iwama S, De Remigis A, Callahan MK, Slovin SF, Wolchok JD, Caturegli P. Pituitary expression of CTLA-4 mediates hypophysitis secondary to administration of CTLA-4 blocking antibody. Sci Transl Med. 2014 Apr 2;6(230):230ra45. doi: 10.1126/scitranslmed.3008002.
* 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
Responsible Party	Bristol-Myers Squibb
Study Sponsor	Bristol-Myers Squibb
Collaborators	Not Provided
Investigators	Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account	Bristol-Myers Squibb
Verification Date	May 2013