Study of Ipilimumab (MDX-010) 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	January 7, 2009
Start Date ^ICMJE	April 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2006)	estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00289640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2006)	estimate progression free survival rate at Week 12 assessment and other timepoints estimate disease control rate at various time points estimate overall survival estimate survival rate at one year evaluate health-related quality of life obtain pharmacokinetic samples for population PK analysis
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Official Title ^ICMJE	A Randomized, Double-Blind, Multi-Center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary	The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	Drug: ipilimumab (MDX-010, BMS-734016) Drug: Ipilimumab
Study Arms / Comparison Groups
Publications *
* 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	210
Completion Date	July 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Gender	Both
Ages	16 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, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, South Africa

Administrative Information
NCT ID ^ICMJE	NCT00289640
Responsible Party	Study Director, Bristol-Myers Squibb
Study ID Numbers ^ICMJE	CA184-022
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Medarex
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP