Vemurafenib + Cobimetinib for Craniopharyngioma

Recruiting in Palo Alto (17 mi)

+122 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Eligibility Criteria

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

I don't have a history of prolonged QT syndrome.

My kidney function is normal or only slightly reduced.

Absolute neutrophil count >= 1500/mm^3

Treatment Details

Interventions

• Cobimetinib (Kinase Inhibitor)
• Vemurafenib (Kinase Inhibitor)

Trial Overview The effectiveness of two drugs, vemurafenib and cobimetinib, is being tested on stopping the growth of this type of brain tumor by blocking enzymes needed for cell growth. The study will assess how well these drugs work together in treating this condition.

Participant Groups

Group I: Treatment (vemurafenib, cobimetinib) Experimental Treatment 4 Interventions

Patients receive vemurafenib PO BID on day 1-28 and cobimetinib PO QD on days 1-21. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive radiation therapy, surgery, or continued treatment with vemurafenib and cobimetinib at the discretion of the treating physician.

Cobimetinib is already approved in European Union, United States, Canada, Switzerland, Japan for the following indications:

🇪🇺 Approved in European Union as Cotellic for:

• Melanoma

🇺🇸 Approved in United States as Cotellic for:

• Melanoma

🇨🇦 Approved in Canada as Cotellic for:

• Melanoma

🇨🇭 Approved in Switzerland as Cotellic for:

• Melanoma

🇯🇵 Approved in Japan as Cotellic for:

• Melanoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Marie Yeager Cancer Center Saint Joseph, MI

Fred Hutchinson Cancer Center Seattle, WA

University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, FL

Bronson Battle Creek Battle Creek, MI

More Trial Locations

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology Lead Sponsor

National Cancer Institute (NCI) Collaborator

References