Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma
1 other identifier
interventional
8
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2010
CompletedFirst Posted
Study publicly available on registry
November 22, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJune 12, 2013
June 1, 2013
1.8 years
November 19, 2010
June 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
BMS-908662 or Ipilimumab (A)
EXPERIMENTALBMS-908662 or Ipilimumab (B)
EXPERIMENTALInterventions
Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uncontrolled or significant cardiovascular disease
- Cohort expansion: Prior therapy with a RAF inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Jedd D. Wolchok, Md,Phd
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2010
First Posted
November 22, 2010
Study Start
January 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
June 12, 2013
Record last verified: 2013-06