RecruitingEarly Phase 1

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

United States24 participantsStarted 2025-04-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Prior RAF dimer disruptor or pan-RAF inhibitor not allowed
✓. Prior immunotherapy allowed
✓. Prior RAF dimer disruptor or pan-RAF inhibitor allowed,
✓. Prior immunotherapy not allowed (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathway).

What they're measuring

Detection rate of BRAF-V600E ctDNA in CSF and/or plasma

Timeframe: surgery, baseline (C1D1) and pre-cycle 2 (week 4)

Trial details

NCT IDNCT06610682

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Study Chair, MD

410-955-8837 ksolt1@jhmi.edu

View on ClinicalTrials.gov More BRAF V600E Mutation trials