AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE)

This research study, called EPILOGUE, is exploring new ways to treat children and young people who have a specific type of brain tumour called paediatric low-grade glioma (pLGG). This is for cases where the tumour has either returned, grown, or hasn't responded to previous treatments. Researchers are testing different combinations of medicines, specifically Vinblastine Sulfate Teva and Tovorafenib, to see how safe they are together and how well they work at shrinking the tumour. The study will involve regular check-ups over about two years, looking at how patients respond and any side effects they might experience. The goal is to find better treatment options for these young patients.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Universitaetsklinikum Heidelberg AöR

Enrolment target

Start

17 Mar 2026

progressive/relapsed/refractory pediatric low-grade glioma (pLGG)

What is this study about?

This study is called EPILOGUE, and it's looking into new ways to help children and teenagers with a type of brain tumour called paediatric low-grade glioma (pLGG). This kind of tumour sometimes grows or comes back even after treatment, or doesn't react to treatment in the first place. When this happens, doctors need more options, and that's exactly what this study is trying to find.

Researchers are testing combinations of two specific medicines: Vinblastine Sulfate Teva and Tovorafenib. Both these drugs are already used to treat certain conditions, but the study wants to see if using them together is a safe and effective way to fight pLGG. They will be carefully watching for any side effects and seeing if the tumours shrink or stop growing.

The main aim is to understand the safest doses of these combined treatments and how well they make the tumour respond. They will be checking patients regularly to see how things are going and to make sure the treatment is as safe and helpful as possible. Information from studies like EPILOGUE helps doctors learn how to give the best care to young people with brain tumours.

Key takeaways

Tests new combination treatments for a type of brain tumour (pLGG).
Aimed at helping tumours that have come back or are getting worse.
Uses existing medicines: Vinblastine Sulfate Teva and Tovorafenib.
Monitors safety and how well tumours respond to treatment.
Participation involves regular check-ups for up to two years.

Who may be eligible?

This study is open to both male and female patients who are 18 years old or older. You could be considered for this study if you have paediatric low-grade glioma (pLGG) that has either progressed (gotten worse), relapsed (come back), or is refractory (hasn't responded well to previous treatments).

The term "paediatric" in pLGG refers to the type of tumour which usually starts in childhood, but the study itself is for adults who still have this condition. Your doctors will need to check other specific medical requirements to make sure this study is the right fit 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.

Am I 18 years old or older?
Do I have paediatric low-grade glioma (pLGG)?
Has my pLGG come back, gotten worse, or not responded to previous treatments?
Am I able to attend regular appointments for scans and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either Vinblastine Sulfate Teva, Tovorafenib, or a combination of both. You will have regular appointments, likely every 8 weeks, for about two years. During these visits, doctors will monitor your health, check for any changes in your tumour using scans, and look for any side effects from the medication. You will be on the study treatment for up to 12 cycles, which is about 24 months. After this, you will still have follow-up checks to see how you're doing in the long term. All medication and tests related to the study will be provided.

Potential risks and benefits

Taking part in a study like this might offer a chance to try new treatments that aren't widely available yet, which could potentially help shrink your tumour or control its growth. However, all medicines have potential side effects, and combining them might bring new or stronger side effects. The research team will carefully monitor you for any problems. You're always in control; you have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

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Unverified
Denmark
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Unverified
Czechia
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Unverified
Austria
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Unverified
Sweden
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Unverified
Germany

Common questions

What is paediatric low-grade glioma (pLGG)?

It's a type of slow-growing brain tumour that typically starts in children, but can continue to affect people into adulthood.

Are the study drugs new?

Vinblastine Sulfate Teva and Tovorafenib are existing medicines, but this study is looking at using them together in new combinations for pLGG.

How long will I be in the study?

You could be on the study treatment for up to 12 cycles (about 2 years), with follow-up appointments after that.

What kind of tests will I have?

You'll have regular scans and check-ups to see how the tumour is responding and to monitor your overall health and any side effects.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your ongoing medical care.