Melanoma
Conditions
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.
Interventions
DRUGBMS-908662
Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
DRUGIpilimumab
Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed