Clincosm LogoSign in Get a demo

Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01245556
Collaborator
(none)
8
Enrollment
2
Locations
2
Arms
22
Duration (Months)
4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-908662 or Ipilimumab (A)

Drug: BMS-908662
Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously

Drug: Ipilimumab
Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
Experimental: BMS-908662 or Ipilimumab (B)

Drug: BMS-908662
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

Drug: Ipilimumab
Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Efficacy as determined by estimates of objective response rates and response duration [Efficacy measured every 6 weeks until week 48, then every 12 weeks]

  2. 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]

  3. PD will be assessed by evaluating markers of RAS/RAF pathway activity [PD assessed during the first 4 weeks on study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
2 Jedd D. Wolchok, Md,Phd New York New York United States 10065

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01245556
Other Study ID Numbers:
  • CA206-005
First Posted:
Nov 22, 2010
Last Update Posted:
Jun 12, 2013
Last Verified:
Jun 1, 2013
Additional relevant MeSH terms:
Melanoma
Ipilimumab

Study Results

No Results Posted as of Jun 12, 2013