Plixorafenib with or without Retifanlimab for BRAF-altered Glioma
This study is testing a treatment for adults with a specific type of brain tumor called BRAF V600E mutant glioma that has not responded to previous treatments. Researchers want to see if a drug called plixorafenib, given alone or with another drug called retifanlimab, can help. Plixorafenib is taken daily by mouth, and retifanlimab is also given. The main goal is to see how well a test can find tumor DNA (ctDNA) in spinal fluid (CSF) and blood plasma before and after treatment. This study is looking for 24 participants and is currently unclear if it's recruiting. To join, you must have received prior BRAF and/or MEK inhibitor therapy.
- Study design
- This is a pilot study involving 24 participants. It will evaluate the effects of plixorafenib alone or in combination with retifanlimab.
- What's involved
- Participants will take plixorafenib daily by mouth for 28-day cycles until the disease progresses or for up to 24 cycles. MRI scans will be performed post-surgery, at the beginning of Cycle 2, and then at the beginning of every odd cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for detecting BRAF-V600E ctDNA is measured at surgery, baseline (C1D1), and pre-cycle 2 (week 4).
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NCT06610682
A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma
Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~24 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:PlixorafenibRetifanlimab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection rate of BRAF-V600E ctDNA in CSF and/or plasma
Measured over surgery, baseline (C1D1) and pre-cycle 2 (week 4)
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Karisa Schreck, MD · STUDY_CHAIR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
Prior RAF dimer disruptor or pan-RAF inhibitor.
Prior immunotherapy (of note prior RAF dimer-disruptor or pan-RAF inhibitor is allowed).
Known history of clinically significant autoimmune disease that, in the opinion of the investigator, may be exacerbated by immune checkpoint blockade (e.g., multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease), with the following exceptions: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment (subjects with a history of flares requiring systemic treatment are excluded), or other autoimmune conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Daily systemic steroids \> 4mg daily dexamethasone or equivalent.
Have received a live vaccine within 28 days before the planned start of study treatment.
Current use of any other standard or investigational agents (excepting tumor treating fields).
Known co-occurring NF1 and/or RAS-related alteration known to cause resistance.
Known hypersensitivity to plixorafenib, retifanlimab or to excipients.
Current use of a prohibited medication (including herbal medications, supplements, or foods), as described in Section 5.6, or use of a prohibited medication ≤ 7 days prior to first infusion of retifanlimab.
Impairment in gastrointestinal function or disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
Clinically significant cardiovascular disease including, but not limited to the following:
History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary artery bypass grafting, coronary angioplasty or stenting ≤ 180 days prior to start date;
Congestive heart failure requiring treatment (New York Heart Association Grade \> 2);
History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
QTcF interval ≥ 480 ms.
History of recent (≤ 90 days) thromboembolic or cerebrovascular event such as transient ischemic attack, cerebrovascular accident, or hemodynamically significant (massive or sub-massive) deep vein thrombosis or pulmonary emboli (DVT/PE). Note: Patients with DVT/PE that does not result in hemodynamic instability may enroll as long as the participants are anticoagulated for at least 4 weeks. Note: Patients with DVT/PE related to indwelling catheters or other procedures may enroll.
Known history of any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus. Subjects with previously treated viral hepatitis and undetectable virus may be eligible.
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible.
Pregnant women are excluded from this study because the effects of plixorafenib or retifanlimab on a fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with plixorafenib, breastfeeding should be discontinued if the mother is treated on study.
Contraindication to ventricular reservoir placement or biospecimen collection.
Current use of strong inhibitors or inducers of CYP3A.
What this trial measures
- Detection rate of BRAF-V600E ctDNA in CSF and/or plasmasurgery, baseline (C1D1) and pre-cycle 2 (week 4)
Proportion of patients with detectable ctDNA in CSF and/or plasma detected at surgery, baseline (C1D1), and pre-Cycle 2 (week 4).