What is the mechanism of action of this treatment?

The PEPIDH1M vaccine aims to stimulate the immune system to recognize and attack cells harboring the IDH1 mutation, potentially reducing tumor growth by targeting a specific genetic alteration. Vorasidenib, on the other hand, inhibits the mutant IDH1 and IDH2 enzymes, which are involved in the production of an oncometabolite that promotes tumor growth. By blocking these enzymes, Vorasidenib can slow down or halt the progression of the tumor. These treatments are significant for LGG patients as they offer targeted therapeutic options that specifically address the molecular abnormalities driving their cancer, potentially leading to more effective and personalized treatment strategies.

What side effects are associated with this type of intervention?

Treatments for low-grade glioma, such as the PEPIDH1M vaccine and Vorasidenib, can cause various side effects. Immune-based therapies may lead to immune-related adverse events (irAEs) including colitis, hepatitis, endocrinopathies, and skin reactions. Vorasidenib, which targets mutant IDH1 and IDH2 enzymes, may cause fatigue, nausea, elevated liver enzymes, and hematologic abnormalities. These side effects are typical of targeted and immune therapies used in glioma treatment.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Low Grade Glioma that directly target IDH1 and IDH2 mutations or utilize immune response mechanisms similar to the PEPIDH1M vaccine and Vorasidenib. Current standard treatments for Low Grade Glioma typically involve surgery, radiation therapy, and chemotherapy, with temozolomide being a commonly used chemotherapeutic agent. Investigational therapies, such as the PEPIDH1M vaccine and Vorasidenib, are being studied to provide more targeted and potentially effective treatment options for patients with IDH1 mutant lower grade gliomas.

What other types of research exist?

Promising novel alternatives for low-grade glioma patients include: 1) Bevacizumab, an anti-VEGF antibody, which has shown efficacy in various neuro-oncological conditions including NF2-related schwannomatosis. 2) Everolimus, an mTORC1 inhibitor, which has demonstrated potential in treating progressive vestibular schwannomas and meningiomas. 3) Lapatinib, a dual EGFR and HER2 inhibitor, which has been effective in other cancers and may offer benefits in gliomas with relevant mutations. These alternatives should be discussed with a healthcare provider to determine the best personalized treatment plan.

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Cancer Vaccine

Vaccine + Vorasidenib for Brain Cancer (ViCToRy Trial)

Phase 1

Waitlist Available

Led By Katherine Peters, MD, PhD

Research Sponsored by Katy Peters, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

IDH1R132H expression in primary tumor

Karnofsky Performance Status (KPS) of ≥ 70

Must not have

Prior therapy with mIDH1 targeted therapeutics

Unstable angina and/or congestive heart failure requiring hospitalization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects may include reactions related to the immune system due to the vaccine, liver issues because vorasidenib affects enzymes in the liver, as well as general side effects like fatigue or digestive problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My primary tumor tests positive for IDH1R132H.

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I am able to care for myself but may not be able to do active work.

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I am 18 years old or older.

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My condition has returned only once.

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My brain tumor is growing and is larger than 2 cm in one direction without contrast enhancement.

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I have recovered from any major side effects of surgery for brain cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with mIDH1 targeted therapy before.

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I have been hospitalized for heart issues recently.

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I do not have any major stomach or bowel issues that affect how I absorb medicine taken by mouth, except for treated acid reflux.

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My cancer has spread to the lower part of my brain or beyond.

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I have not had a heart attack in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glioma

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 gliomas

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The PEPIDH1M vaccine aims to stimulate the immune system to recognize and attack cells harboring the IDH1 mutation, potentially reducing tumor growth by targeting a specific genetic alteration. Vorasidenib, on the other hand, inhibits the mutant IDH1 and IDH2 enzymes, which are involved in the production of an oncometabolite that promotes tumor growth. By blocking these enzymes, Vorasidenib can slow down or halt the progression of the tumor. These treatments are significant for LGG patients as they offer targeted therapeutic options that specifically address the molecular abnormalities driving their cancer, potentially leading to more effective and personalized treatment strategies.

Input of molecular analysis in medical management of primary brain tumor patients.