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

3 1

What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Oncopole Claudius Regaud	Toulouse	France
Medical University Of Vienna	Vienna	Austria
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Instituto Di Ricovero E Cura A Carattere Scientifico	Bologna	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Kepler Universitaetsklinikum GmbH	Linz	Austria
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Vrije Universiteit Brussel	Jette	Belgium
Anquokmac Uyu	Amsterdam	The Netherlands
Amtqfuctfd Peqyhsxr Hlkuhihx Dn Mxmbedihr	Marseille	France
Epzgyiv Utzrsxkbokmx Muvzsbx Clpwufl Rsbeczyhy (vjluyur Mas	Rotterdam	The Netherlands
Armmuql Oivyusvhpmo Uacvflydsstpu Cvkhncioieee Dvacn Sjcivn E Dasqz Spgfmih Df Tbhspy	Turin	Italy
Gvqmyh Usdgpbsbcf Fnmczmdms	Frankfurt	Germany
Hovdzngb Dx Ly Svqnx Cmbe I Sezz Pvs	Barcelona	Spain
Uzgupikuwj Djplc Smzpt Dh Ramw Ly Skzxpfwk	Rome	Italy
Hrvurkcr Vbaq dgsqvgmc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	22.12.2025
Belgium	Recruiting	22.12.2025
Czechia	Recruiting	22.12.2025
France	Recruiting	22.12.2025
Germany	Recruiting	22.12.2025
Italy	Recruiting	22.12.2025
Spain	Recruiting	22.12.2025
The Netherlands	Recruiting	22.12.2025

Trial locations

Investigated drugs:

Vorasidenib

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.

Investigated diseases:

Astrocytoma malignant

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 ID:

2024-519404-27-00

Protocol code:

EORTC-2427-BTG

NCT ID:

NCT06809322

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?