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MAPK Inhibitor

Binimetinib + Encorafenib for Recurrent Brain Cancer (BRAF Trial)

Phase 2
Waitlist Available
Led By Karisa C Schreck, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be 18 years of age or older.
Patients must be able to swallow tablets and capsules.
Must not have
History of recent thromboembolic or cerebrovascular event.
Patients who previously received BRAF or MEK inhibitors are excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 year
Awards & highlights

Summary

This trial is testing a new combination of drugs to see if it can shrink tumors in people with a type of brain cancer that has come back.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include muscle pain or weakness (myopathy), inflammation of the pancreas (pancreatitis), blocked blood vessels in the eye (retinal vein occlusion), liver issues due to Hepatitis B/C reactivation, skin reactions at drug application sites, increased risk of infection from HIV/Hepatitis B/C.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can swallow pills.
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I am mostly able to care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a recent blood clot or stroke.
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I have never taken BRAF or MEK inhibitors.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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My tumor does not have a RAS activating mutation.
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I have heart problems or significant heart disease.
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I am not pregnant.
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I am allergic to binimetinib, encorafenib, or their ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Secondary outcome measures
Duration of Response - Complete and Partial
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Overall Survival
+1 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encorafenib
2022
Completed Phase 3
~970
Binimetinib
2018
Completed Phase 3
~1100
Tumor Tissue
2012
N/A
~500

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
563 Previous Clinical Trials
33,319 Total Patients Enrolled
2 Trials studying Gliosarcoma
76 Patients Enrolled for Gliosarcoma
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,396 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,829 Patients Enrolled for Gliosarcoma
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,765 Total Patients Enrolled
1 Trials studying Gliosarcoma
23 Patients Enrolled for Gliosarcoma

Media Library

Binimetinib (MAPK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03973918 — Phase 2
Gliosarcoma Research Study Groups: Surgical Arm, Treatment Cohort 1 AA & GBM, Treatment Cohort 2 anaplastic PXAs, Treatment Cohort 3 Other Tumors
Gliosarcoma Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT03973918 — Phase 2
Binimetinib (MAPK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03973918 — Phase 2
~1 spots leftby Jul 2025
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