A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma
Both
Melanoma
Trial Information
A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma
Inclusion Criteria:
- Previously untreated, metastatic melanoma with activating V600
Serine/threonine-protein kinase B-Raf (BRAF) mutation
- Measurable Tumor
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion Criteria:
- Autoimmune disease
- Active Brain Metastases (with symptoms or requiring corticosteroid treatment)
- Prior therapy with immunosuppressive agents (within the past 2 years) and any
anti-cancer therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of Ipilimumab treated subjects with Grade 3-4 drug related skin adverse events (AEs) during the sequence of Vemurafenib and Ipilimumab
Outcome Time Frame:
9 weeks after the last subject's first dose (LPFT) of Ipilimumab
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:
CA184-240
NCT ID:
NCT01673854
Start Date:
October 2012
Completion Date:
August 2014
Related Keywords:
- Melanoma
- Melanoma
Name | Location |
|---|---|
| Mount Sinai School of Medicine | New York, New York 10029 |
| MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Winship Cancer Institute | Atlanta, Georgia 30322 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Baptist Cancer Institute | Jacksonville, Florida 32207 |
| New Mexico Cancer Care Alliance | Albuquerque, New Mexico 87106 |
| Duke University Hospital | Durham, North Carolina 27710 |
| Levine Cancer Institute | Charlotte, North Carolina 28211 |
| Beverly Hills Cancer Center | Beverly Hills, California 90211 |
