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

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

Tracking Information

• First Submitted Date: December 1, 2005
• First Posted Date: December 5, 2005
• Last Update Posted Date: September 29, 2016
• Study Start Date: November 2005
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: December 1, 2005): Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-010 (BMS734016)

Current Secondary Outcome Measures (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 (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: Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Unresectable Stage III or IV Malignant Melanoma

Intervention

• 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

• Active Comparator: A1
  Intervention: Drug: Ipilimumab
• Active Comparator: A2
  Intervention: Drug: Ipilimumab

Publications *

• Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
• Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gómez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: December 1, 2005): 80
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2007
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, Israel, Italy, Norway, Peru, Sweden, United States
• Removed Location Countries: Australia, Canada, United Kingdom

Administrative Information

• NCT Number: NCT00261365
• Other Study ID Numbers: CA184-004
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Study Director, Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: August 2008