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Vorasidenib for patients with IDH-mutant grade 2 or 3 astrocytoma after completing first-line chemoradiotherapy

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What is this trial about?

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

This study involves patients with IDH-mutant grade 2 or 3 astrocytoma, which is a type of brain tumor that has a specific change in its genetic makeup. The treatment being tested is vorasidenib, also known by its code name S95032. This medication comes as a tablet that is taken by mouth. Some patients in the study will receive vorasidenib while others will receive placebo tablets that look the same but contain no active medication. The purpose of this study is to find out if vorasidenib can help slow down tumor growth better than placebo in patients who have completed their first standard treatment with radiation and chemotherapy.

Patients joining this study will have already undergone surgery for their brain tumor and completed their first course of treatment, which includes radiation therapy followed by chemotherapy with either temozolomide or PCV. The study medication or placebo will be given as a maintenance treatment, meaning it is intended to help keep the disease under control after the initial treatment is finished. Patients must start taking the study medication between six and twelve weeks after finishing their last dose of chemotherapy. The study will continue for several years to collect information about how well the treatment works.

During the study, patients will be monitored regularly with brain scans to check if the tumor is growing or staying stable. The main measure of success will be how long patients go without their tumor getting worse, which is called progression-free survival. Doctors will also look at other factors such as overall survival, how patients feel in their daily lives, any side effects from the medication, and how well their brain functions. Safety will be carefully tracked throughout the study to understand any problems that might occur with the treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment and treatment start

    Your treatment will begin between 6 and 12 weeks after your last dose of first-line chemotherapy.

    Before starting, blood tests will be performed to check your bone marrow, kidney, and liver function.

    If you are a woman of childbearing potential, a pregnancy test will be conducted within 72 hours before your first dose.

    Your corticosteroid dose (if you are taking any) must be stable or decreasing for at least 7 days before starting.

  2. Step 2

    Daily oral medication

    You will receive either vorasidenib or placebo tablets. The study is triple-blind, meaning neither you, your doctor, nor the study team will know which treatment you are receiving.

    The medication is taken orally as a film-coated tablet.

    You will take the medication daily throughout the maintenance treatment period.

    The specific dosage and exact duration of treatment will be determined by the study protocol and your individual response.

  3. Step 3

    Regular monitoring and imaging

    Throughout the study, your disease progression will be monitored using brain imaging scans.

    These scans will be assessed locally by your medical team using RANO 2.0 criteria, which are standardized guidelines for evaluating brain tumor response to treatment.

    The imaging will also be reviewed later by independent experts for additional assessment.

  4. Step 4

    Safety and side effect monitoring

    Your safety will be monitored throughout the study according to standardized criteria for tracking side effects.

    Any side effects from the previous chemotherapy and radiation treatment should have resolved or be stable and manageable before you start.

    Regular blood tests and physical examinations will be conducted to monitor your health.

  5. Step 5

    Quality of life and neurological assessments

    Your quality of life will be regularly assessed using standardized questionnaires.

    Your neurological symptoms and signs will be evaluated using the NANO scale, which tracks neurological function.

    Your cognitive function will be tested using a battery of tests that assess memory, thinking speed, verbal fluency, and sleep quality.

    Seizure control will be monitored if applicable to your condition.

  6. Step 6

    Birth control requirements

    If you are of childbearing or reproductive potential, you must use two methods of birth control during the study.

    This includes one highly effective method and one barrier method.

    Birth control must continue for at least 90 days after your last dose of study treatment.

  7. Step 7

    Continuation of treatment

    You will continue taking the study medication daily as maintenance therapy.

    Treatment will continue until your disease progresses, unacceptable side effects occur, or you decide to discontinue.

    The study will track your progression-free survival, which measures the time from enrollment until your disease worsens or you pass away.

  8. Step 8

    Long-term follow-up

    After completing or discontinuing treatment, you will continue to be followed for long-term outcomes.

    This includes monitoring your overall survival and tracking when you might need additional treatment for your condition.

    The study is expected to continue follow-up until August 2036.

Who can join the trial?

12 criteria

  • You must be able to provide informed consent, which means you understand the study and agree to participate
  • You must be 18 years of age or older
  • You must have a confirmed diagnosis of astrocytoma (a type of brain tumor) that is IDH-mutant (a specific genetic change in the tumor), grade 2 or 3 (indicating how fast the tumor grows). This diagnosis must include documented proof of an IDH1 or IDH2 mutation based on testing of your tumor tissue
  • You must have had at least one prior surgery for your brain tumor
  • You must have completed first-line standard of care radiotherapy (radiation treatment of at least 50.4 Gy, which is a measure of radiation dose) followed by standard of care chemotherapy (either 4 to 12 cycles of a drug called temozolomide or 2 to 6 cycles of a combination called PCV)
  • Your last dose of chemotherapy (cancer-fighting medication) must have been given more than 6 weeks but less than 12 weeks before joining the study
  • You must have recovered from any significant side effects of your previous treatment, unless these side effects are stable and manageable in your doctor's opinion
  • You must have adequate bone marrow (the tissue inside bones that makes blood cells), kidney, and liver function. This includes having normal levels of ALT and AST (enzymes that show how well your liver is working)
  • You must have a WHO performance status of 0 to 2, which means you are able to care for yourself and carry out daily activities, though you may have some limitations
  • If you are taking corticosteroids (medications that reduce swelling and inflammation), your dose must be stable or decreasing, or you must not be using them at all, for at least 7 days before joining the study
  • If you are a woman of childbearing potential, you must have a negative pregnancy test within two weeks before joining the study, and another negative test within 72 hours before starting the study treatment
  • If you are able to have children, you must use two adequate methods of birth control, including one highly effective method and a barrier method, during the study and for at least 90 days after your last dose of study treatment

Who cannot join the trial?

5 criteria

  • You cannot participate if you have a different type of brain tumor than the one specified in this study (which is IDH-mutant grade 2 or 3 astrocytoma, a specific type of brain cancer with a particular genetic change)
  • You cannot participate if you have not completed your first chemoradiotherapy treatment (a combination of chemotherapy, which uses drugs to kill cancer cells, and radiotherapy, which uses radiation to destroy cancer cells)
  • You cannot participate if your tumor does not have the IDH mutation (a specific genetic change in the tumor cells that affects how they grow)
  • You cannot participate if your tumor is a different grade than 2 or 3 (grade refers to how abnormal the cancer cells look under a microscope and how quickly the tumor is likely to grow)
  • You cannot participate if you have had previous treatment beyond the first-line chemoradiotherapy
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Investigated drugs

  • Vorasidenib

    is an experimental medication being tested in this clinical trial as a maintenance treatment for patients with a specific type of brain tumor called IDH-mutant astrocytoma. This medication is given after patients complete their initial treatment with chemotherapy and radiation therapy. The purpose of vorasidenib is to help prevent the tumor from growing or coming back after the first-line treatment is finished.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against vorasidenib to determine if vorasidenib truly works better than no active treatment. Patients receiving placebo will not know they are taking an inactive substance, as this is a blinded study.

What is already known about the treatment

Vorasidenib – Vorasidenib is an oral medication taken by mouth that is currently being studied in clinical trials as a potential treatment for certain types of brain tumors called IDH-mutant astrocytomas. This drug works by blocking abnormal enzymes (mutated IDH proteins) that cause cancer cells to grow and survive, helping to slow down or stop tumor progression at the molecular level. In the VIGOR study, vorasidenib is being tested as a maintenance therapy given after patients complete their initial chemotherapy and radiation treatment, with the goal of preventing the cancer from getting worse. It belongs to a class of medications known as IDH inhibitors, which specifically target genetic mutations found in some brain cancers.

Investigated diseases

  • IDH-mutant grade 2 astrocytoma

    This is a type of brain tumor that develops in star-shaped brain cells called astrocytes. The tumor has a mutation in the IDH gene, which affects how cells process energy. Grade 2 indicates that the tumor grows relatively slowly compared to higher-grade tumors. The cells look somewhat abnormal under a microscope but are not as aggressive as higher-grade forms. This type of tumor can occur in different parts of the brain and may cause symptoms such as seizures, headaches, or neurological problems depending on its location. Over time, these tumors may continue to grow and potentially progress to higher grades.

  • IDH-mutant grade 3 astrocytoma

    This is a brain tumor that forms in astrocytes, the star-shaped cells that support nerve cells in the brain. Like grade 2, it has a mutation in the IDH gene, but grade 3 tumors are more aggressive and grow faster. The cells appear more abnormal when examined under a microscope compared to grade 2 tumors. These tumors can cause various symptoms including seizures, headaches, weakness, or changes in thinking and behavior depending on where they are located in the brain. Grade 3 astrocytomas are considered high-grade tumors that require close monitoring. They have a greater tendency to grow and spread within the brain tissue compared to lower-grade tumors.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519404-27-00Protocol codeEORTC-2427-BTGEstimated enrolment468 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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