Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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 combination with ipilimumab.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab

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