36
Participants
Start Date
October 31, 2012
Primary Completion Date
August 16, 2024
Study Completion Date
August 16, 2024
Vemurafenib
Patients will receive vemurafenib at a dose of 960mg orally b.i.d. continuously in cycles of 4 weeks (28 days) as outpatient. A bone marrow aspirate and/or biopsy will be performed after the first cycle for research purposes only. After the completion of the third cycle, a repeat bone marrow aspirate and/or biopsy will be performed for assessment of response and evaluation of MRD. Following the third cycle assessments, patients who achieve complete response (CR) with detectable MRD or partial response (PR) may continue with vemurafenib for up to 3 additional cycles at the treating physician's discretion (Cycles 4-6). Patients who achieve CR without MRD will be observed as part of post-treatment followup, and may be re-treated with vemurafenib after relapse (as per below). Patients who achieve no response (NR) after the initial 3 cycles of vemurafenib will be removed from the study. They will be followed every 3 months as part of posttreatment followup for a total of 12 months.
Memorial Sloan Kettering Cancer Center, New York
Ohio State University, Columbus
Northwestern University, Evanston
Scripps Clinic, La Jolla
Dana Farber Cancer Institute, Boston
Collaborators (1)
National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Ohio State University
OTHER
Dana-Farber Cancer Institute
OTHER
Scripps Clinic
OTHER
Northwell Health
OTHER
Memorial Sloan Kettering Cancer Center
OTHER