RecruitingEarly Phase 1NCT06610682

A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma

A Trial to Evaluate Deoxyribonucleic) in BRAF (V-raf Murine Sarcoma Viral Oncogene Homolog B1)-Altered Glioma During Treatment With Plixorafenib Alone or With Retifanlimab

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

24 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

BRAF V600E Mutation

Summary

The investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline (defined as C1D1) and over time in response to treatment with plixorafenib alone or in combination with retifanlimab in patients with BRAF-V600E mutant glioma refractory to prior therapies.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether liquid biopsies from blood or spinal fluid (detecting cancer DNA called ctDNA) can track how well a targeted brain tumor treatment called plixorafenib is working in adults with BRAF-mutated glioma (a type of brain cancer). Rather than always relying on brain MRI scans, researchers want to see if these simpler fluid tests can provide similar information. **You may be eligible if...** - You are 18 years or older - You have a brain tumor with a confirmed BRAF-V600E mutation (verified by an approved genetic test) - You have already received prior treatment with a BRAF or MEK inhibitor - You have measurable disease on brain MRI - Your overall health is adequate (Karnofsky score of 70 or above) **You may NOT be eligible if...** - You have not had prior BRAF/MEK-targeted treatment - Your immune system is not adequate or you have uncontrolled active infections - You have not recovered from prior treatment side effects Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlixorafenib

Patients will start the study drug (plixorafenib 900mg daily 30 minutes after a full meal or meal supplement) 7-28 days post-operatively, when clinically stable. Patients will take the drug daily by mouth continuously for 28-day cycles until progressive disease or up to 24 cycles. MRI will be performed post-operatively (between surgery and start of study drug) for evaluation of measurable disease, at the beginning of Cycle 2, then at the beginning of every odd cycle. Blood and CSF samples will be obtained on day of surgery, C1D1 (baseline), pre-C2 (week 4) and with every odd cycle up to and including C7 and EOT.

DRUGRetifanlimab

Investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline and over time in response to treatment with plixorafenib alone or in combination with retifanlimab in patients with BRAF-V600E mutant glioma refractory to prior therapies.

Locations(1)

Johns Hopkins

Baltimore, Maryland, United States

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NCT06610682