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Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

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.
 
ClinicalTrials.gov Identifier: NCT00261365
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : September 29, 2016
Sponsor:
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 1, 2005
First Posted Date  ICMJE December 5, 2005
Last Update Posted Date September 29, 2016
Study Start Date  ICMJE November 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016) [ Time Frame: on a continuous & ongoing basis ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2005)
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-010 (BMS734016)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Safety & tumor response are important secondary objectives. Safety evaluated [ Time Frame: on a continuous & ongoing basis ]
  • Tumor response measured [ Time Frame: starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2005)
Safety & tumor response are important secondary objectives. Safety evaluated on a continuous & ongoing basis. Tumor response measured starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
Official Title  ICMJE An Exploratory Study to Determine Potential Predictive Markers of Response and/or Toxicity in Patients With Unresectable Stage III or IV Malignant Melanoma Randomized and Treated With Ipilimumab (MDX-010/BMS-734016) at Two Dose Levels
Brief Summary The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Unresectable Stage III or IV Malignant Melanoma
Intervention  ICMJE
  • Drug: Ipilimumab
    Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
    Other Names:
    • BMS-734016
    • (MDX-010)
  • Drug: Ipilimumab
    Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
    Other Names:
    • BMS-734016
    • (MDX-010)
Study Arms  ICMJE
  • Active Comparator: A1
    Intervention: Drug: Ipilimumab
  • Active Comparator: A2
    Intervention: Drug: Ipilimumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 1, 2005)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Israel,   Italy,   Norway,   Peru,   Sweden,   United States
Removed Location Countries Australia,   Canada,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00261365
Other Study ID Numbers  ICMJE CA184-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account 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