Study of Vorasidenib with PEPIDH1M Vaccine to Treat Adults with Recurrent IDH1 Mutant Lower Grade Gliomas

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a vaccine called PEPIDH1M combined with a drug named vorasidenib in adults who have recurrent lower grade gliomas with a specific mutation called IDH1. This study focuses on patients with progressive Grade 2-3 gliomas, aiming to see if this combination can help control the disease while monitoring for any side effects. The trial is a Phase 1 study designed to explore how well the treatments work together and how safe they are for patients. Participants will first receive a tetanus and diphtheria vaccine injection to build immunity before starting vorasidenib, which is taken orally once a day for 28-day cycles. After two cycles of vorasidenib, patients will begin receiving the PEPIDH1M vaccine through injections in the groin area on a specific schedule alongside continued vorasidenib treatment. Vaccinations continue at set intervals during the treatment cycles, with patients receiving up to 14 cycles of vorasidenib and multiple vaccine doses throughout the study. A safety lead-in phase will be conducted to check for any serious side effects before fully starting the treatment. During the study, patients will be closely monitored for side effects such as skin reactions at vaccine sites and possible liver or heart-related issues from vorasidenib. Assessments include imaging scans, blood tests, and evaluations of disease progression and survival. The main outcomes measured are safety over 3.5 years and progression-free survival over 10 years. Patients will attend regular visits for treatment and monitoring, and researchers will track how the combination affects tumor control and patient health throughout the study period.

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