Active not recruitingPHASE1INTERVENTIONAL

Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors

This study is investigating a new way to treat certain brain tumours in children and teenagers (aged 2 to 18). It combines two medicines, Avelumab and Lenvatinib, which are designed to target cancer cells in different ways. The study has two main parts. The first part will help doctors work out the safest and most effective dose of these medicines when given together. The second part will then look more closely at how well this drug combination works for patients with specific types of brain tumours, especially those that have grown or returned after other treatments. The goal is to find better treatment options for young people facing this challenging condition.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

Start

03 Dec 2021

Estimated completion

29 May 2026

Central Nervous System Tumors

What is this study about?

This research study is focused on children and teenagers between 2 and 18 years old who have certain types of brain tumours. The study is exploring a new treatment approach that uses two different drugs, Avelumab and Lenvatinib, given together. These drugs aim to fight cancer in different ways, and combining them might be more effective than using them alone. Doctors want to understand if this combination is safe and how well it works for these particular brain tumours.

Brain tumours are complex, and finding effective treatments for young people is very important. This study is trying to add to our understanding and potentially offer a new option, especially for tumours that have been difficult to treat with current methods or have grown back after initial treatment. The researchers will be carefully monitoring participants to ensure their safety while learning about the drugs' effects.

The study is divided into two stages. The first stage is about finding the right amount (dose) of each drug to give that is both safe and has the best chance of working. Once the best dose is found, the second stage will involve more young people to confirm how effective this drug combination is. This is a common way new treatments are tested to make sure they are developed responsibly and safely.

Key takeaways

This study evaluates two drugs, Avelumab and Lenvatinib, for children and teenagers with certain brain tumours.
It aims to find the safest dose and see how well the treatment works.
Participants are aged 2 to 18 years with specific high-grade brain tumours.
Monitoring includes regular check-ups, blood tests, and MRI scans.
Participation could offer a new treatment option for eligible individuals.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, participants must be between 2 and 18 years old and have a specific type of brain tumour that has been diagnosed by examining a tissue sample. For most, their tumour should be considered high-grade (more aggressive) and they must have already received at least one other treatment for their tumour that didn't fully work or the tumour has grown back. However, for those with a specific type called 'diffuse midline glioma', they might be eligible even if they've only had radiotherapy and no prior drug treatment.

Participants also need to be well enough to take part. This is measured by how active they are, for example, being able to do most everyday activities for their age. Doctors will also need to see that the tumour can be measured on scans, which helps them track if the treatment is working.

There are also some reasons why someone might not be able to join the study. This includes having less aggressive (low-grade) tumours, or if their brain tumour is causing new or worsening neurological problems in the week before starting the study. Certain large tumours or tumours that are pressing on important brain areas, or uncontrolled seizures, would also prevent participation, as these situations might make the study treatment unsafe or difficult to manage.

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 or your child between 2 and 18 years old?
Has a doctor confirmed the brain tumour type by looking at a tissue sample?
Has the tumour either grown back or not responded well to at least one previous treatment? (For diffuse midline glioma, previous radiotherapy alone might be enough).
Is the person well enough to do most everyday activities for their age?
Does the tumour show on scans in a way that doctors can measure it?
Are there no signs of new or worsening neurological problems (like weakness or balance issues) in the week before starting treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll have regular appointments at the hospital. These will involve check-ups, blood tests, and scans (like MRI scans) to see how you're responding to the treatment and to keep an eye on your general health. You'll be taking two study medications, Avelumab and Lenvatinib, as guided by the study doctors. The doctors will monitor you closely for any side effects.

The study is split into two parts. In the first part, the focus is on finding the safest and most effective dose of the drugs. In the second part, more people will receive the treatment at this chosen dose to see how well it works over a longer period. The total duration someone stays on treatment will depend on how they respond and whether any side effects develop. After finishing the treatment part, there will likely be follow-up visits to continue monitoring your health and the tumour's status.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. While this new treatment combination aims to help children and teenagers with brain tumours, there's no guarantee it will work for everyone. You might experience side effects from the medications, which the doctors will explain to you and monitor carefully throughout the study. However, you would be helping researchers learn more about potential new treatments for these difficult conditions. It's important to remember that joining is always voluntary, and you have the right to withdraw from the study at any time without explaining your reasons or affecting your future medical care.

Locations (9)

CHU Sainte-Justine
Verified postcode
Montreal, Canada
The Hospital for Sick Children
Verified postcode
Toronto, Canada
CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique
Verified postcode
Angers, France
Hôpital de la Timone
Verified postcode
Marseille, France
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
Verified postcode
Paris, France
Universitaetsklinikum Hamburg Eppendorf
Verified postcode
Hamburg, Germany
Universitaetsklinikum Muenster
Verified postcode
Münster, Germany
Seoul National University Hospital
Verified postcode
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Verified postcode
Seoul, South Korea

Common questions

What kind of brain tumours is this study looking at?

This study is focused on specific types of primary brain tumours that are considered more aggressive, or 'high-grade', in children and teenagers.

What are Avelumab and Lenvatinib?

These are two different medicines that are being tested together. They work in different ways to try and fight cancer cells.

Will I or my child definitely get the new treatment?

If you meet the study criteria, you would receive the Avelumab and Lenvatinib combination. There is no placebo in this study.

How long would I need to be in the study?

The length of time you'd be involved can vary, depending on how you respond to the treatment and study requirements. Your doctors will discuss this with you.

Can I leave the study at any time?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.