Back to resultsSafety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-908662
BMS-908662
Ipilimumab
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility 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
Sites / Locations
- H. Lee Moffitt Cancer Center & Research Institute
- Jedd D. Wolchok, Md,Phd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BMS-908662 or Ipilimumab (A)
BMS-908662 or Ipilimumab (B)
Arm Description
Outcomes
Primary Outcome Measures
Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Secondary Outcome Measures
Efficacy as determined by estimates of objective response rates and response duration
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
PD will be assessed by evaluating markers of RAS/RAF pathway activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01245556
Brief Title
Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-908662 or Ipilimumab (A)
Arm Type
Experimental
Arm Title
BMS-908662 or Ipilimumab (B)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-908662
Intervention Description
Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
Intervention Type
Drug
Intervention Name(s)
BMS-908662
Intervention 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, Continuously
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
PD will be assessed by evaluating markers of RAS/RAF pathway activity
Time Frame
PD assessed during the first 4 weeks on study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Jedd D. Wolchok, Md,Phd
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
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