Vemurafenib + Cobimetinib for Craniopharyngioma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Will I have to stop taking my current medications?
You may need to stop taking certain medications. If you are on medications that are strong CYP3A4 inducers or inhibitors, or CYP1A2 substrates, you must stop them at least 14 days before joining the study.
How is the drug combination of Vemurafenib and Cobimetinib unique for treating craniopharyngioma?
The combination of Vemurafenib and Cobimetinib is unique for treating craniopharyngioma because it specifically targets the BRAF-V600E mutation found in the papillary variant of this tumor, offering a non-surgical option that avoids the serious risks associated with surgery and radiotherapy, such as blindness and cognitive impairment.12345
What data supports the effectiveness of the drug combination Vemurafenib and Cobimetinib for treating craniopharyngioma?
Who Is on the Research Team?
Priscilla K. Brastianos, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for patients with a specific brain tumor called BRAF V600E mutation positive craniopharyngioma. Eligible participants must have measurable disease, may or may not have received prior surgery, and should not have had previous treatment with BRAF or MEK inhibitors. Women of childbearing potential need a negative pregnancy test to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vemurafenib orally twice daily on days 1-28 and cobimetinib once daily on days 1-21. Treatment repeats every 28 days for up to 5 courses.
Follow-up
Participants are monitored for disease progression or unacceptable toxicity. Patients with disease progression are followed up every 16 weeks for 2 years, and all other patients are followed up every 6 months for 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Cobimetinib
- Vemurafenib
Cobimetinib is already approved in European Union, United States, Canada, Switzerland, Japan for the following indications:
- Melanoma
- Melanoma
- Melanoma
- Melanoma
- Melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator