Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
- Registration Number
- NCT01245556
- Lead Sponsor
- Bristol-Myers Squibb
- 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 combination with ipilimumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-908662 or Ipilimumab (B) Ipilimumab - BMS-908662 or Ipilimumab (A) Ipilimumab - BMS-908662 or Ipilimumab (A) BMS-908662 - BMS-908662 or Ipilimumab (B) BMS-908662 -
- Primary Outcome Measures
Name Time Method Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 Assessments approximately every 3 weeks throughout the duration of the trial
- Secondary Outcome Measures
Name Time Method Efficacy as determined by estimates of objective response rates and response duration 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 PK measured during first 4 weeks on study PD will be assessed by evaluating markers of RAS/RAF pathway activity PD assessed during the first 4 weeks on study
Trial Locations
- Locations (2)
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Jedd D. Wolchok, Md,Phd
🇺🇸New York, New York, United States