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

PHASE1RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 15, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2029

Conditions
Low Grade Glioma of Brain
Interventions
DRUG

PEPIDH1M 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.

Trial Locations (1)

27710

RECRUITING

Duke University Medical Center, Durham

All Listed Sponsors
collaborator

Servier

INDUSTRY

lead

Katy Peters, MD, PhD

OTHER