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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
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, Continuously
Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Jedd D. Wolchok, Md,Phd
New York, New York, United States
Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Time frame: Assessments approximately every 3 weeks throughout the duration of the trial
Efficacy as determined by estimates of objective response rates and response duration
Time frame: Efficacy measured every 6 weeks until week 48, then every 12 weeks
PK for BMS-908662 as determined by minimum and maximum observed concentrations, time of maximum observed concentration, area under the concentration curve for one dosing interval and the accumulation index
Time frame: PK measured during first 4 weeks on study
PD will be assessed by evaluating markers of RAS/RAF pathway activity
Time frame: PD assessed during the first 4 weeks on study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously