Actively Recruiting
A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-04-16
24
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
F
Fore Biotherapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must have received prior BRAF and/or MEK inhibitor therapy
- No prior RAF dimer disruptor or pan-RAF inhibitor for Arm A; allowed for Arm B
- No prior immunotherapy for Arm B; allowed for Arm A
- Intervals from prior treatments: BRAFi/MEKi stopped 2 weeks before surgery (Arm A) or 7 days before retifanlimab infusion and 2 weeks before surgery (Arm B)
- Stable or decreasing systemic corticosteroid dose prior to screening MRI
- Histologic diagnosis of primary CNS tumor with documented BRAF-V600E mutation by CLIA-approved DNA or RNA test
- Karnofsky performance status of 70 or higher
- Age 18 years or older
- Measurable disease by RANO 2.0 on screening MRI; leptomeningeal disease allowed
- Willing to submit archival tumor sample if available
- Specified intervals elapsed from prior radiation, anti-VEGF therapy, chemotherapy, and investigational agents
- Adequate organ and marrow function as defined by specified blood counts and lab values
- Able to provide written informed consent
- Resolved adverse events from prior therapies to Grade 1 or baseline, with some exceptions
- Ability to swallow and retain oral medications
- Female participants of childbearing potential must have negative pregnancy test and use contraception or abstinence
- Male participants must be surgically sterile or use contraception
- No concurrent malignancy except certain treated cancers or disease-free for over 2 years
- Life expectancy of at least six months
You will not qualify if you...
- Prior RAF dimer disruptor or pan-RAF inhibitor (Arm A only)
- Prior immunotherapy (Arm B only)
- Significant autoimmune disease that could worsen with immune checkpoint blockade, except certain controlled conditions
- Daily systemic steroids over 4 mg dexamethasone or equivalent
- Live vaccine within 28 days before starting treatment
- Use of other standard or investigational agents, except tumor treating fields
- Known NF1 or RAS-related alterations causing resistance
- Known allergy to plixorafenib, retifanlimab, or excipients
- Use of prohibited medications within 7 days before retifanlimab infusion
- Gastrointestinal problems affecting absorption of oral plixorafenib
- Significant cardiovascular disease or recent serious cardiac events
- Recent thromboembolic or cerebrovascular events, with some exceptions
- Positive tests for active hepatitis B or C infection
- Uncontrolled infection or psychiatric/social conditions limiting compliance
- Pregnant or breastfeeding women
- Contraindications to ventricular reservoir placement or biospecimen collection
- Use of strong CYP3A inhibitors or inducers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
S
Study Chair, MD
CONTACT
P
Principal Investigator, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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