Active not recruitingPHASE3INTERVENTIONAL

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

This study, called INDIGO, is looking for people aged 12 and over who have a specific brain tumour called Grade 2 glioma. This is for tumours that weren't fully removed by surgery or have returned. You must have had surgery as your only treatment so far, at least one year and no more than five years ago. The study focuses on gliomas with a particular gene change called an IDH1 or IDH2 mutation, which will be checked carefully. Participants will be given either a new drug called vorasidenib or a dummy pill (placebo) once a day. The main aim is to see if vorasidenib can help stop the tumour from growing and reduce the need for other treatments like chemotherapy or radiotherapy.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Institut de Recherches Internationales Servier

Enrolment target

331

Start

05 Jan 2020

Estimated completion

01 May 2028

Grade 2 Glioma Residual Glioma Recurrent Glioma

Results

Results from this study

Posted November 2023

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS)

PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier.

Full results on the registry

What is this study about?

This study, known as INDIGO, is investigating a new medication called vorasidenib for a specific type of brain tumour called Grade 2 glioma. Gliomas are tumours that grow in the brain or spinal cord. In this study, we're focusing on Grade 2 gliomas, which are generally slower-growing but can still cause problems. Your tumour must also have a specific genetic change, or 'mutation', called IDH1 or IDH2, which will be carefully checked.

The main goal of this study is to see if vorasidenib can help people whose Grade 2 glioma was not completely removed by surgery or has come back after surgery. It's designed for people who have only had surgery for their tumour and no other treatments like chemotherapy or radiotherapy. We want to find out if taking vorasidenib can prevent the tumour from growing further, potentially delaying the need for more intensive treatments.

To do this, some participants will receive vorasidenib, and others will receive a dummy pill (placebo). This is a standard way to test new medicines fairly, so researchers can compare the effects of the new drug against not having it. This helps us understand if vorasidenib is truly effective and safe for people with this type of brain tumour.

Key takeaways

This study is testing a new drug for a specific brain tumour (Grade 2 glioma with an IDH mutation).
It's for people who have only had surgery for their tumour, at least one year ago.
You'll either receive the new drug (vorasidenib) or a dummy pill (placebo) once daily.
The main goal is to see if the drug can stop the tumour from growing.
Your tumour's genetic makeup (IDH1 or IDH2 mutation) must be confirmed.
Regular MRI scans and check-ups will monitor your health and tumour's progress.

Who may be eligible?

This study is looking for people who are at least 12 years old and weigh at least 40 kg. You must have a Grade 2 oligodendroglioma or astrocytoma, which are specific types of brain tumours, confirmed by the most recent World Health Organisation (WHO) standards.

You should have had surgery for your brain tumour at least one year ago, but no more than five years ago. This surgery must have been your only treatment for the tumour so far – you shouldn't have had any chemotherapy, radiotherapy, or other anti-cancer drugs. It's also important that your doctors don't believe you need chemotherapy or radiotherapy straight away when you join the study. Your tumour must have a specific genetic change (an IDH1 or IDH2 mutation), which will be confirmed by a special test.

Finally, the tumour should be measurable on an MRI scan, and you need to be generally well enough to take part. This is assessed by a score called the Karnofsky Performance Scale or Lansky Play Performance Scale, which needs to be 80% or higher. You cannot take part if you've had any anti-cancer treatment other than surgery, or if your doctors think your tumour is in a high-risk area or causing significant, uncontrolled problems like severe seizures.

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 at least 12 years old and weigh at least 40 kg?
Do you have a Grade 2 oligodendroglioma or astrocytoma brain tumour?
Was your last brain tumour surgery at least 1 year ago, but no more than 5 years ago?
Has surgery been your ONLY treatment for this brain tumour so far (no chemotherapy or radiotherapy)?
Do your doctors believe you don't need chemotherapy or radiotherapy immediately?
Do you have a KPS or LPPS score of 80% or better (meaning you are generally quite active and independent)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: one group will receive the study drug, vorasidenib, and the other will receive a dummy pill (placebo). You will take the assigned pill once a day. Neither you nor your study doctor will know which you are receiving, as this helps to ensure the results are accurate and unbiased.

Before starting, you'll have specific tests to confirm your tumour's genetic makeup and measure its size. Throughout the study, you'll have regular visits for check-ups, blood tests, and MRI scans to monitor your health and how the tumour is responding. The exact number of visits isn't specified here, but you can expect them to be ongoing to closely track your progress and any side effects. You'll continue taking the study medication for as long as it's helping and you're not experiencing severe side effects, or until the study concludes. There will also be follow-up appointments after you stop taking the study drug to monitor your health in the long term.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A potential benefit of this study is that vorasidenib might help to slow or stop the growth of your brain tumour, potentially delaying the need for other treatments like chemotherapy or radiotherapy. However, it's also possible that the drug may not work for you, or you might receive the placebo. Potential risks could include side effects from the study drug, which will be carefully monitored by the study team. Every effort will be made to minimise any discomfort or risks. You will be closely monitored by medical professionals, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (84)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
City of Hope
Verified postcode
Duarte, United States
University of California San Diego
Verified postcode
La Jolla, United States
UCLA Oncology Center
Verified postcode
Los Angeles, United States
University of California Irvine - Hospital
Verified postcode
Orange, United States
University of California San Francisco
Verified postcode
San Francisco, United States
Stanford Cancer Center
Verified postcode
Stanford, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Verified postcode
Aurora, United States
Yale University, Yale Cancer Center
Verified postcode
New Haven, United States
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States
Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics
Verified postcode
Miami, United States
Northwestern University
Verified postcode
Chicago, United States

Common questions

What is a Grade 2 glioma?

A Grade 2 glioma is a type of brain tumour that typically grows slower than higher-grade types. The 'Grade 2' refers to how the cells look under a microscope.

What is an IDH1 or IDH2 mutation?

These are specific changes in certain genes within the tumour cells. Knowing if your tumour has this mutation helps doctors understand the tumour better and decide on the best treatments.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It's used in studies to fairly compare the effects of the new drug.

Can I still have traditional treatments like chemo or radiotherapy if I join?

No, this study is specifically for people who have only had surgery for their tumour and haven't had chemotherapy, radiotherapy, or other anti-cancer treatments yet.

What does being 'randomised 1:1' mean?

It means you have an equal 50/50 chance of being assigned to either the group receiving vorasidenib or the group receiving the dummy pill (placebo), much like flipping a coin.