Binimetinib + Encorafenib for Recurrent Brain Cancer (BRAF Trial)

Palo Alto (17 mi)

Overseen byKarisa C Schreck, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this study is to estimate the efficacy of encorafenib and binimetinib as measured by radiographic response in recurrent high-grade primary brain tumors.

Eligibility Criteria

Adults with recurrent high-grade brain tumors and BRAF V600 mutation can join. They must be over 18, have measurable disease by MRI, good organ function, no severe neuromuscular disorders or uncontrolled infections like HIV/Hepatitis B/C (with exceptions), not on certain medications, able to swallow pills, and agree to contraception. Those with other cancers must be disease-free for 2 years.

Inclusion Criteria

I am 18 years old or older.

I can swallow pills.

I am mostly able to care for myself but may need occasional help.

Exclusion Criteria

I have had a recent blood clot or stroke.

I have never taken BRAF or MEK inhibitors.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

My tumor does not have a RAS activating mutation.

I have heart problems or significant heart disease.

I am not pregnant.

I am allergic to binimetinib, encorafenib, or their ingredients.

Treatment Details

The trial is testing the effectiveness of two drugs—Encorafenib and Binimetinib—in treating recurrent brain tumors by observing changes in tumor size through MRI scans. Participants will take these oral medications under specific conditions regarding prior treatments and health status.

4Treatment groups

Experimental Treatment

Group I: Treatment Cohort 3 Other TumorsExperimental Treatment4 Interventions

Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods

Group II: Treatment Cohort 2 anaplastic PXAsExperimental Treatment4 Interventions

Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods

Group III: Treatment Cohort 1 AA & GBMExperimental Treatment4 Interventions

Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods

Group IV: Surgical ArmExperimental Treatment4 Interventions

Pre-op -14 days: Encorafenib 450mg QD and Binimetinib 45mg BID last dose of both drugs 2hrs prior to surgery Tumor; research blood; CSF samples post surgery: Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle

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

🇺🇸 Approved in United States as Mektovi for: