ViCToRy: Vorasidenib and Vaccine for IDH1 Mutant Gliomas
This study is testing a combination of two treatments for adults with a specific type of brain tumor called recurrent IDH1 mutant lower grade glioma. The treatments are PEPIDH1M vaccine and vorasidenib. Vorasidenib is a medication that targets specific enzymes (IDH1 and IDH2) found in these tumors. To join, your tumor must show the IDH1R132H mutation and be progressing. The study aims to see how safe this combination is and how well it prevents the tumor from growing (progression-free survival). The study plans to enroll 48 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 48 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive a tetanus and diphtheria toxoids (Td) vaccination, then take vorasidenib daily for 28-day cycles. After two cycles of vorasidenib, you would start receiving the PEPIDH1M vaccine, with additional doses given over several cycles. You will receive up to 14 cycles of vorasidenib.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess safety for 3.5 years and progression-free survival for 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
At a glance
Conditions
NCT05609994
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Medical Center
Durham, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Katherine Peters, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- To assess the safety of the PEPIDH1M vaccine in combination vorasidenib in adult patients with progressive IDH1 mutant World Health Organization (WHO) Grade 2-3 gliomas3.5 years
The proportion of patients with an unacceptable toxicity
- Describe the efficacy, as measured by progression-free survival (PFS), of the combination of PEPIDH1M vaccine and vorasidenib in adult patients with recurrent IDH1 lower grade glioma10 years
The time between initiation of cycle 1 vorasidenib and first documentation of disease progression or death