Status:
COMPLETED
Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combinat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01245556
Start Date
January 1 2011
End Date
November 1 2012
Last Update
June 12 2013
Active Locations (2)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
2
Jedd D. Wolchok, Md,Phd
New York, New York, United States, 10065