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

This study has been completed.
Sponsor:
Collaborator:
Medarex
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00289640
First received: February 9, 2006
Last updated: February 27, 2010
Last verified: January 2009

February 9, 2006
February 27, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   France,   South Africa,   Hungary,   Germany,   Australia,   Belgium,   Brazil,   Canada
 
NCT00289640
CA184-022
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