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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 year
Awards & highlights

BRAF Trial 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.

BRAF Trial 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.

BRAF Trial 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

BRAF 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
2021
Completed Phase 3
~960
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
557 Previous Clinical Trials
32,895 Total Patients Enrolled
2 Trials studying Gliosarcoma
76 Patients Enrolled for Gliosarcoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,516 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,820 Patients Enrolled for Gliosarcoma
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,435 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Encorafenib been tested in any other research investigations?

"First trialled in 2011 at LMU Klinikum der Universität, encorafenib has since been the focus of 30 completed studies. At present, 63 active investigations are taking place around Philadelphia, Pennsylvania."

Answered by AI

Does this clinical experiment constitute a precedent?

"As of now, there are 63 live clinical trials for Encorafenib happening in 41 nations and 1256 cities. Pfizer has been the primary sponsor since first launching this study back in 2011 with 183 patients. Since then, 30 other trials have concluded."

Answered by AI

How many facilities are offering this clinical experiment?

"This trial can be accessed at Abrams Cancer Center of the University of Pennsylvania in Philadelphia, Henry Ford Hospital in Detroit, UAB Comprehensive Cancer Centre in Birmingham and several other medical locations."

Answered by AI

What is the current enrollment capacity of this research project?

"This trial has already reached its recruitment goals and is no longer accepting participants. First posted on July 29th 2019, the study was last updated August 5th 2022. For those still seeking clinical trials for gliosarcoma, there are currently 497 studies recruiting patients; 63 of which involve Encorafenib as a potential treatment option."

Answered by AI

Is enrollment still open for this investigation?

"Presently, this medical trial is not recruiting participants. It was posted on July 29th 2019 and the last update to its information was on August 5th 2022. Alternatively, there are 497 trials for gliosarcoma and 63 trials utilizing Encorafenib that are currently seeking volunteers."

Answered by AI

What ailments is Encorafenib commonly prescribed to ameliorate?

"Patients with the BRAF V600K mutation, metastatic melanoma, and unresectable melanoma have been known to respond positively to encorafenib."

Answered by AI

Has Encorafenib received the endorsement of the FDA?

"Our team at Power rated Encorafenib a 2 on the safety scale due to its phase 2 status and the lack of clinical data backing up its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
2019. "Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03973918.
~1 spots leftby Apr 2025
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