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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289640
First Posted: February 10, 2006
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medarex
Information provided by:
Bristol-Myers Squibb
February 9, 2006
February 10, 2006
March 2, 2010
April 2006
July 2007   (Final data collection date for 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.
Same as current
Complete list of historical versions of study NCT00289640 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Melanoma
  • Drug: ipilimumab (MDX-010, BMS-734016)
    IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
  • Drug: Ipilimumab
    IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
  • Drug: Ipilimumab
    IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
  • Experimental: 1
    Intervention: Drug: ipilimumab (MDX-010, BMS-734016)
  • Experimental: 2
    Intervention: Drug: Ipilimumab
  • Experimental: 3
    Intervention: Drug: Ipilimumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Hungary,   South Africa,   United States
Argentina,   Chile,   United Kingdom
 
NCT00289640
CA184-022
Not Provided
Not Provided
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Medarex
Not Provided
Bristol-Myers Squibb
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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