Vaccine + Vorasidenib for Brain Cancer
(ViCToRy Trial)

Recruiting in Palo Alto (17 mi)

Overseen byKatherine Peters

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Katy Peters, MD, PhD

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine and a daily pill to treat adults with a specific type of brain tumor that has a certain mutation. The vaccine helps the body fight the tumor, and the pill stops the tumor from growing.

Research Team

Katherine Peters

Principal Investigator

Duke University

Eligibility Criteria

Adults over 18 with a first recurrence of IDH1 mutant lower grade gliomas, who have recovered from prior treatments and have good organ function. They must not be pregnant or breastfeeding, agree to use contraception, and should not have severe medical conditions that could interfere with the trial.

Inclusion Criteria

My primary tumor tests positive for IDH1R132H.

You are expected to live for at least 12 more months.

I am 18 years old or older.

See 18 more

Exclusion Criteria

I have been treated with mIDH1 targeted therapy before.

I have been hospitalized for heart issues recently.

Unable to undergo MRI imaging

See 16 more

Treatment Details

Interventions

PEPIDH1M vaccine (Cancer Vaccine)
Vorasidenib (Enzyme Inhibitor)

Trial OverviewThe trial is testing the combination of PEPIDH1M vaccine and vorasidenib in patients with recurrent brain tumors (lower grade gliomas). It aims to assess how safe this combo is and how well it works against these tumors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PEPIDH1M vaccine + vorasidenibExperimental Treatment1 Intervention

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.