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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3

Outcome Time Frame:

Assessments approximately every 3 weeks throughout the duration of the trial

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA206-005

NCT ID:

NCT01245556

Start Date:

January 2011

Completion Date:

November 2012

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Jedd D. Wolchok, Md,PhdNew York, New York  10065