RecruitingPhase 1NCT05609994

ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas

Sponsor

Katy Peters, MD, PhD

Enrollment

48 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Low Grade Glioma of Brain

Summary

The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study combines vorasidenib (an IDH inhibitor drug) with a personalized tumor vaccine for people whose low-grade brain tumor (glioma, grade 2 or 3) has come back for the first time. The tumor must have a specific genetic marker called IDH1 R132H mutation. **You may be eligible if...** - You are 18 years or older - Your brain tumor biopsy shows IDH1 R132H expression - You have a grade 2 or 3 glioma that has progressed for the first time (first recurrence only) - There is more than 2 cm of non-enhancing disease visible on brain MRI - Your performance status is good (Karnofsky ≥ 70) and expected survival is at least 12 months - You are willing to use contraception during the study **You may NOT be eligible if...** - Your tumor does not have the IDH1 R132H mutation - This is not your first recurrence - Your overall health status is too poor to tolerate the treatment 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

DRUGPEPIDH1M vaccine + vorasidenib

Patients will receive vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids) intramuscularly into the deltoid muscle. Patients will then receive vorasidenib 40mg orally once a day for 28 days. After two cycles of 28-day vorasidenib and at the start of the 3rd cycle of vorasidenib, patients will receive the PEPIDH1M vaccine intradermally (i.d.) to alternating groin regions on the following schedule: vaccine #1, day 1; vaccine #2, day 15. The day before vaccine #1, patients will receive a vaccine site pre-conditioning injection of a single dose of Td toxoid. This will be administered twelve hours to one day prior to receiving PEPIDH1M vaccine i.d. to the RIGHT groin area. Vaccines #3 and #4 will be given on day 1 and day 15 of cycle 4. Starting on 6th cycle of 28-day vorasidenib, subjects will receive PEPIDH1M vaccine (i.d. to alternating groin regions) every 28 days on day 1 for vaccine #5-#12. Patients will receive up to a total of 14 cycles of vorasidenib.