A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma
Both
Melanoma
Trial Information
A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma
Inclusion Criteria
Inclusion:
- Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis
of Stage III or Stage IV (unresectable) melanoma
- Enrollment to cohort expansion will be limited to only those subjects whose tumors
demonstrate the B-Raf V600E mutation
- ECOG ≤ 1
- Adequate organ & marrow function
Exclusion:
- Uncontrolled or significant cardiovascular disease
- Cohort expansion: Prior therapy with a RAF inhibitor
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Outcome Time Frame:
Assessments approximately every 3 weeks throughout the duration of the trial
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA206-005
NCT ID:
NCT01245556
Start Date:
January 2011
Completion Date:
November 2012
Related Keywords:
- Melanoma
- Melanoma
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
| Jedd D. Wolchok, Md,Phd | New York, New York 10065 |
