Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma - Tabular View

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Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

This study has been completed.

Study NCT00289640. Last updated on August 13, 2008. Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	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.
Secondary Outcome Measure ^†	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
Condition ^†	Melanoma
Intervention ^†	Drug: ipilimumab (MDX-010, BMS-734016) Drug: Ipilimumab
MEDLINE PMIDs
Links	BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	210
Start Date ^†	April 2006
Completion Date	July 2007
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, South Africa

Administrative Information Fields
NCT ID ^†	NCT00289640
Organization ID	CA184-022
Secondary IDs ^††
Study Sponsor ^†	Bristol-Myers Squibb
Collaborators ^††	Medarex
Investigators ^†
Information Provided By	Bristol-Myers Squibb
Verification Date	August 2008
First Received Date ^†	February 9, 2006
Last Updated Date	August 13, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.