Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
Status: Recruiting
Phase: Phase 2
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01673854
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-304
The purpose of this study is to determine whether the sequence of 6 wk vemurafenib followed by ipilimumab monotherapy has an acceptable safety profile with regards to the skin
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Overall PI:
Frank Stephen Hodi, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Donald Lawrence, MD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Suzanne MacRae, 617-632-5906,
smacrae@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
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