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Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of brain tumor called Grade 2 glioma, which can either be residual or come back after treatment. These tumors have specific changes in their genes known as IDH1 or IDH2 mutations. The study is testing a new treatment called vorasidenib, also known by its code name S95032/AG-881. This medication is taken as a tablet by mouth and is being compared to a placebo to see how well it works in treating this type of glioma.

The purpose of the study is to see if vorasidenib can help slow down the growth of the tumor when compared to a placebo. Participants in the study will be randomly assigned to receive either the vorasidenib tablets or placebo tablets. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, which is known as a double-blind study. The treatment period can last up to 96 weeks, and participants will have regular check-ups and imaging tests like MRI to monitor the tumor's response to the treatment.

Throughout the study, the safety of vorasidenib will be closely monitored by checking for any side effects or changes in health. Participants will also have their blood tested to understand how the body processes the medication. The study aims to provide valuable information on whether vorasidenib can be an effective treatment option for people with Grade 2 glioma with IDH1 or IDH2 mutations.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to receive either the study drug vorasidenib or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  2. Step 2

    Medication administration

    Participants take the assigned medication orally. The study drug, vorasidenib, is provided in the form of film-coated tablets. The dosage and frequency of administration are determined by the study protocol and communicated to participants by the study team.

  3. Step 3

    Regular assessments

    Participants undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments include imaging tests to evaluate the progression of the glioma, as well as blood tests to measure the concentration of the drug and its metabolites in the body.

  4. Step 4

    Safety monitoring

    Throughout the study, participants are monitored for any adverse effects. This includes regular checks of vital signs, heart function through electrocardiograms (ECGs), and overall health status using performance scales.

  5. Step 5

    Study completion

    The study is expected to continue until May 2028. Upon completion, participants may undergo final assessments to evaluate the long-term effects of the treatment.

Who can join the trial?

6 criteria

  • Be at least 12 years old and weigh at least 40 kilograms.
  • Have a type of brain tumor called **Grade 2 oligodendroglioma** or **astrocytoma** according to the WHO 2016 criteria.
  • Have had at least one previous surgery for the brain tumor, with the last surgery being at least 1 year ago but not more than 5 years ago. No other cancer treatments like chemotherapy or radiotherapy should have been received, and there should be no immediate need for these treatments according to the doctor's opinion.
  • Have a confirmed **IDH1** or **IDH2 gene mutation** in the tumor, which is a specific change in the genes, confirmed by a central laboratory test. Also, have available information on **1p19q status**, which is another genetic detail, tested by an accredited laboratory.
  • Have a brain tumor that can be measured by an **MRI** scan, which is a type of imaging test, and the tumor should not be enhancing, as confirmed by a special review committee.
  • Have a **KPS score** of 80% or higher if 16 years or older, or an **LPPS score** of 80% or higher if younger than 16 years. These scores measure the ability to perform daily activities.

Who cannot join the trial?

8 criteria

  • Patients who have not had surgery as their only treatment for their brain tumor.
  • Patients who do not have a specific type of brain tumor called **Grade 2 glioma** with an **IDH1** or **IDH2 mutation**. These are specific changes in the genes of the tumor cells.
  • Patients who have a different type of brain tumor than **oligodendroglioma** or **astrocytoma**. These are specific types of brain tumors.
  • Patients who are not within the age range specified for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

Vorasidenib is a medication being studied for its effectiveness in treating certain types of brain tumors called oligodendroglioma and astrocytoma. These tumors have specific genetic changes known as IDH1 or IDH2 mutations. Vorasidenib is being tested to see if it can help slow down the growth of these tumors in patients who have already had surgery.

What is already known about the treatment

Vorasidenib – Vorasidenib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating residual or recurrent Grade 2 glioma with IDH1 or IDH2 mutations. The main therapeutic indication for vorasidenib is to improve progression-free survival in patients with these specific types of brain tumors. At the molecular level, vorasidenib works by inhibiting the mutated IDH1 and IDH2 enzymes, which are involved in the abnormal cell growth seen in these tumors. It is classified pharmacologically as an IDH1/2 inhibitor.

Investigated diseases

Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation – This is a type of brain tumor that arises from glial cells, which support and protect nerve cells in the brain. It is characterized by a mutation in the IDH1 or IDH2 genes, which are involved in cellular metabolism. These tumors are classified as Grade 2, indicating they are low-grade and grow more slowly than higher-grade gliomas. Despite their slower growth, they can still infiltrate surrounding brain tissue, making them challenging to completely remove surgically. Over time, these gliomas may recur or persist even after initial treatment, such as surgery. The presence of the IDH mutation can influence the behavior and progression of the tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512961-15-00Protocol codeAG881-C-004Estimated enrolment340 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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