Plain-English translation of NCT05609994 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing vorasidenib, a daily medication, combined with a personalized vaccine called PEPIDH1M in patients whose lower-grade brain gliomas have returned. The vaccine is designed to train your immune system to recognize and fight cancer cells with a specific genetic mutation. Researchers want to see if using both treatments together is safe and helps control the tumor.
When lower-grade brain tumors come back after initial treatment, options are limited and outcomes can be poor. This trial is exploring whether combining this medication with a personalized vaccine—which harnesses your own immune system—might offer a better chance of slowing or stopping tumor growth.
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You will first receive a tetanus shot in your arm. Then you'll take a daily pill (vorasidenib 40 mg) for 14 cycles of 28 days each (about 14 months total). Starting in the 3rd cycle, you'll also receive the personalized vaccine injected into your groin area multiple times on a set schedule. You'll need regular blood tests and imaging scans to monitor how you're responding. The trial includes a safety check-in period at the start to make sure the combination is tolerable before more participants join.
AI-generated summary from trial data · Jun 13, 2026 · Not medical advice
United States
Phase
Safety & dosing
Sponsor
Katy Peters, MD, PhD
Collaborators
Servier
Enrollment target
~48 participants
Started
July 2025
Primary completion
August 2027
Age range
18 Years and older
Last updated on clinicaltrials.gov in July 2025.
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Central contact
Katherine Peters, MD, PhD
Duke University
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.