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.
Name: BMS-908662
Description: Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, ContinuouslyType: DrugBMS-908662 or Ipilimumab (A)
Name: BMS-908662
Description: Capsules, Oral, escalating doses starting at 25 mg Q 12 h daily for 3 weeks with 3 weeks interval for 4 cycles, then Q12 h daily for 3 weeks every 12 weeks, ContinuouslyType: DrugBMS-908662 or Ipilimumab (B)
Name: Ipilimumab
Description: Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, ContinuouslyType: DrugBMS-908662 or Ipilimumab (A)
Name: Ipilimumab
Description: Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, ContinuouslyType: DrugBMS-908662 or Ipilimumab (B)
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
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 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 Melanoma Melanoma null --- V600E ---
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 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 Melanoma Melanoma null --- V600E --- --- V600E ---