RecruitingPHASE3INTERVENTIONAL

Vorasidenib Maintenance for IDH Mutant Astrocytoma

This study, called VIGOR, is looking for people with a type of brain tumour called IDH-mutant astrocytoma (Grade 2 or 3). Participants will have already finished their first treatment with radiotherapy and chemotherapy. The study wants to see if a new drug, vorasidenib, can help prevent the tumour from growing back for longer compared to a dummy drug (placebo). Vorasidenib is a tablet taken once a day. This is a Phase 3 study, meaning it's a large trial to confirm if the drug is effective and safe. By participating, you could help scientists understand if this new treatment can offer a better future for people with this condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

468

Start

16 Jan 2026

Estimated completion

31 May 2037

IDH-mutant Grade 2 or 3 Astrocytoma

What is this study about?

This research study is focused on a type of brain tumour called IDH-mutant astrocytoma, specifically Grade 2 or 3. These tumours can be serious, and while current treatments like surgery, radiotherapy, and chemotherapy are available, the tumours can still grow back. Scientists are always looking for new and better ways to treat them.

This study is testing a new tablet called vorasidenib. This drug is designed to target a specific change (mutation) found in some of these brain tumours, called the IDH mutation. The main goal is to find out if taking vorasidenib after your initial chemotherapy and radiotherapy can help stop the tumour from growing back for a longer period compared to taking a dummy pill (placebo).

If vorasidenib proves to be effective, it could offer a new and important treatment option for people living with IDH-mutant astrocytoma. This study is an important step in potentially improving outcomes and quality of life for patients in the future.

Key takeaways

The study is investigating a new drug for a specific brain tumour (IDH-mutant astrocytoma).
It aims to see if the drug can prevent tumour growth after standard treatment.
Participants will take either the study drug or a placebo daily.
Regular MRI scans and check-ups will monitor the tumour.
This is a Phase 3 study, a crucial step before a drug can be widely used.

Who may be eligible?

To join this study, you must be at least 18 years old and have a confirmed diagnosis of IDH-mutant astrocytoma, either Grade 2 or 3. You should have already had surgery for your tumour and completed your first round of radiotherapy followed by chemotherapy (either temozolomide or PCV).

Your body's vital functions, like your blood, kidneys, and liver, need to be working well. Any side effects from your previous treatments should have settled down or be manageable. You also need to be able to provide a sample of your tumour tissue from your previous surgery for further tests. Women who could become pregnant and men whose partners could become pregnant must agree to use reliable birth control during the study and for a period afterwards.

There are also other medical conditions or situations that might prevent you from joining the study, which the medical team will discuss with you. It's important to have an open conversation with your doctor about all your health details to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have IDH-mutant astrocytoma (Grade 2 or 3)?
Have you already had surgery, radiotherapy, and chemotherapy?
Are your kidney, liver, and blood test results generally healthy?
Are you able to use reliable birth control if needed?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups: either you'll receive the new drug, vorasidenib, or a placebo (a tablet that looks exactly like the drug but contains no active medicine). You won't know which one you're taking, and neither will your doctor or the study team, to ensure fair results. You'll take one tablet once a day, every day, in cycles of 28 days.

Participation will involve regular visits to the hospital for checks, which may include blood tests and brain MRI scans. These scans will help the doctors see if your tumour is stable or if it has started to grow. The study will continue for an extended period, and the main goal is to track how long it takes for your tumour to show signs of growth. The specific schedule of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that vorasidenib might help prevent your tumour from growing back for longer than usual. However, there's no guarantee, and you might receive a placebo. Like all medicines, vorasidenib can have side effects, which will be carefully monitored. The study team will explain all known potential side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (33)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Medical University of Innsbruck
Verified postcode
Innsbruck, Austria· Not yet recruiting
Kepler University Hospital - Neuromed campus
Verified postcode
Linz, Austria· Recruiting
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
Universitair Ziekenhuis Brussel
Verified postcode
Brussels, Belgium· Recruiting
Ghent University Hospital
Verified postcode
Ghent, Belgium· Recruiting
U.Z. Leuven - Campus Gasthuisberg
Verified postcode
Leuven, Belgium· Recruiting
Masaryk Memorial Cancer Institute
Verified postcode
Brno, Czechia· Recruiting
Universitary hospital Bordeaux France
Verified postcode
Bordeaux, France· Not yet recruiting
CHU Lyon - Hopital neurologique Pierre Wertheimer
Verified postcode
Lyon, France· Recruiting
Marseille APHM
Verified postcode
Marseille, France· Not yet recruiting
Assistance Publique Hopitaux de Paris APHP - Sorbonne
Verified postcode
Paris, France· Not yet recruiting
Oncopole Claudius Regaud, IUCT-Oncopole
Verified postcode
Toulouse, France· Not yet recruiting

Common questions

What is an IDH-mutant astrocytoma?

It's a specific type of brain tumour that has a change (mutation) in a gene called IDH. This change is important because it can affect how the tumour behaves and how it might respond to certain treatments.

What does 'maintenance therapy' mean?

Maintenance therapy means taking a treatment for a longer period after your initial main treatment has finished. The idea is to keep the tumour from growing back or returning.

Will I definitely get the new drug, vorasidenib?

No. In this study, participants are randomly put into one of two groups: one receives vorasidenib, and the other receives a placebo (a dummy pill). There's a 50/50 chance of getting either.

What is a 'placebo'?

A placebo is a tablet that looks exactly like the study drug but contains no active medication. It's used to compare the effects of the new drug fairly.

What is 'progression-free survival'?

This is how doctors measure if a treatment is working. It refers to the length of time a person lives without their cancer getting worse or growing larger.

How to find out more

EORTC HQ

eortc@eortc.org +32 2 774611 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.