Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
Part of paid clinical trials in Palm Springs, California.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT00261365
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Unresectable Stage III or IV Malignant Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab — DRUGSolution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
- Ipilimumab — DRUGSolution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Study Details
The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
Key Dates
- Start date
- Nov 30, 2005
- Status verified
- Aug 2008
- Primary completion
- Oct 31, 2007
- Completion
- Oct 31, 2007
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: A1
- Active Comparator: A2
Primary Outcome Measure
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016) [ Time Frame: on a continuous & ongoing basis ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Comprehensive Cancer Center | Palm Springs | California | 92262 | - |
| The Angeles Clinic And Research Institution | Santa Monica | California | 90404 | - |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | - |