A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma - Tabular View

Tracking Information
First Received Date ^ICMJE	February 9, 2006
Last Updated Date	August 13, 2008
Start Date ^ICMJE	March 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2006)	Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00289627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2006)	estimate disease control rate estimate progression free survival rate at Week 12 estimate PFS estimate overall survival estimate survival rate at one year estimate duration of BOR evaluate proportion of patients whose duration of response is >=24 weeks estimate time to BOR evaluate safety profile of ipilimumab during the induction and maintenance phases evaluate health-related quality of life obtain PK sample for population PK analysis
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Official Title ^ICMJE	A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary	The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	Drug: ipilimumab (MDX-010, BMS-734016)
Study Arms / Comparison Groups
Publications *	Di Giacomo AM, Danielli R, Guidoboni M, Calabrò L, Carlucci D, Miracco C, Volterrani L, Mazzei MA, Biagioli M, Altomonte M, Maio M. Therapeutic efficacy of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases. Cancer Immunol Immunother. 2009 Aug;58(8):1297-306. Epub 2009 Jan 13.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	150
Completion Date	July 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Austria, Finland, Italy, Norway, Poland, Russian Federation, Spain, Sweden, Ukraine

Administrative Information
NCT ID ^ICMJE	NCT00289627
Responsible Party
Study ID Numbers ^ICMJE	CA184-008
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Medarex
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP