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Kinase Inhibitor

Vemurafenib + Cobimetinib for Craniopharyngioma

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No known history of prolonged QT syndrome

Creatinine =< 1.5 mg/dL OR creatinine clearance >= 45mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests vemurafenib and cobimetinib to treat patients with a certain type of brain tumor. The drugs may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include risks associated with enzyme inhibition that could affect cell growth in other parts of the body, leading to possible organ inflammation, vision changes due to retinal pathology risk factors, heart issues like arrhythmias or congestive heart failure if pre-existing conditions are present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My kidney function is normal or only slightly reduced.

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I have no history of serious eye conditions in the past year.

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I am not taking, and have not taken for the last 14 days, any strong medication that affects liver enzymes.

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My brain tumor is confirmed to be papillary craniopharyngioma with a specific BRAF mutation.

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I haven't had serious heart failure symptoms in the last 6 months.

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I do not have unstable chest pain or uncontrolled heart rhythm problems.

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My blood pressure is controlled and below 150/95 even with medication.

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My cancer can be measured and is visible on an MRI scan.

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I have not been treated with BRAF or MEK inhibitors.

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I do not have a history of chronic lung disease.

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I have a diagnosis of papillary craniopharyngioma with tissue slides for review.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

Overall survival

Progression-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (vemurafenib, cobimetinib)Experimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cobimetinib

2017

Completed Phase 3

~3300

Vemurafenib

2015

Completed Phase 3

~3550