Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
Phase 1
Completed
- Conditions
- Unresectable Stage III or IV Malignant Melanoma
- Interventions
- Registration Number
- NCT00261365
- Lead Sponsor
- Bristol-Myers Squibb
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A1 Ipilimumab - A2 Ipilimumab -
- Primary Outcome Measures
Name Time Method Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016) on a continuous & ongoing basis
- Secondary Outcome Measures
Name Time Method Tumor response measured starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months Safety & tumor response are important secondary objectives. Safety evaluated on a continuous & ongoing basis
Trial Locations
- Locations (4)
Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
The Angeles Clinic And Research Institution
🇺🇸Santa Monica, California, United States
Local Institution
🇸🇪Stockholm, Sweden
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States