Last updated on June 2019

Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the activity of BRAF and MEK inhibitor combination in untreated papillary craniopharyngiomas as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment.

II. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas that have progressed after prior radiation treatment with or without surgical resection as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment.

SECONDARY OBJECTIVES:

I. To determine the progression-free survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.

II. To determine the toxicity of BRAF/MEK inhibitors in patients with papillary craniopharyngiomas.

III. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma.

IV. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma.

V. To determine the overall survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.

VI. To determine the duration of response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.

TERTIARY OBJECTIVES:

I. To evaluate visual fields in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors.

II. To evaluate pituitary hormone replacement over time in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors.

III. To evaluate the time to response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.

IV. To assess toxicity that may be associated with radiotherapy in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors.

V. To evaluate molecular biomarkers of response in papillary craniopharyngiomas.

VI. To evaluate circulating tumor cells and cell-free circulating deoxyribonucleic acid (DNA) in patients with papillary craniopharyngiomas.

OUTLINE

Patients receive vemurafenib orally (PO) twice daily (BID) on day 1-28 and cobimetinib PO once daily (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.

After completion of study treatment, 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.

Clinical Study Identifier: NCT03224767

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Mercy Hospital

Coon Rapids, MN United States
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Kootenai Cancer Center

Post Falls, ID United States
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Mills-Peninsula Medical Center

Burlingame, CA United States
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Farmington Health Center

Farmington, UT United States
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Mercy Health Saint Mary's

Grand Rapids, MI United States
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Eden Hospital Medical Center

Castro Valley, CA United States
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Memorial Medical Center

Modesto, CA United States
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Bronson Battle Creek

Battle Creek, MI United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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West Michigan Cancer Center

Kalamazoo, MI United States
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Borgess Medical Center

Kalamazoo, MI United States
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Mercy Health Mercy Campus

Muskegon, MI United States
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Lakeland Hospital Niles

Niles, MI United States
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Marie Yeager Cancer Center

Saint Joseph, MI United States
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Munson Medical Center

Traverse City, MI United States
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Metro Health Hospital

Wyoming, MI United States
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Fairview Ridges Hospital

Burnsville, MN United States
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Unity Hospital

Fridley, MN United States
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Abbott-Northwestern Hospital

Minneapolis, MN United States
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Hennepin County Medical Center

Minneapolis, MN United States
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Health Partners Inc

Minneapolis, MN United States
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Monticello Cancer Center

Monticello, MN United States
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Mayo Clinic

Rochester, MN United States
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Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, MN United States
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Regions Hospital

Saint Paul, MN United States
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United Hospital

Saint Paul, MN United States
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Lakeview Hospital

Stillwater, MN United States
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Ridgeview Medical Center

Waconia, MN United States
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Rice Memorial Hospital

Willmar, MN United States
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Research Medical Center

Kansas City, MO United States
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Bozeman Deaconess Hospital

Bozeman, MT United States
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Community Medical Hospital

Missoula, MT United States
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M D Anderson Cancer Center

Houston, TX United States
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South Jordan Health Center

South Jordan, UT United States
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Cancer Center of Western Wisconsin

New Richmond, WI United States
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Kootenai Medical Center

Coeur d'Alene, ID United States
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Recruitment Status: Open


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