A Phase I/II Trial of Vemurafenib and Ipilimumab in Subjects With V600 BRAF Mutation-positive Metastatic Melanoma
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma
Both
Melanoma
Trial Information
A Phase I/II Trial of Vemurafenib and Ipilimumab in Subjects With V600 BRAF Mutation-positive Metastatic Melanoma
Inclusion Criteria:
- Metastatic melanoma with activating V600 BRAF mutation
- Measurable Tumor
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Exclusion Criteria:
- Autoimmune disease
- Active Brain Metastasis (must be stable after radiation for at least one month)
- Prior therapy with immune stimulating agents
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase I: Safety and tolerability of combination of Ipilimumab and Vemurafenib as determined by the number and grade of Adverse Event (AEs)/Serious Adverse Events (SAEs)
Outcome Time Frame:
During dose escalation and for up to 12 weeks following the treatment of the last subject in Phase 1
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:
CA184-161
NCT ID:
NCT01400451
Start Date:
November 2011
Completion Date:
January 2014
Related Keywords:
- Melanoma
- Melanoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of California Los Angeles | Los Angeles, California 90095-6951 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Dana-Farber Cancer Inst | Boston, Massachusetts 02115 |
| Dana Farber Cancer Inst | Boston, Massachusetts 02215 |
