AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Phase I study of CDK8 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma; MEDWAY

The MEDWAY study is a new research project focusing on children who have a brain tumour called medulloblastoma. This study is for those whose cancer has returned or is getting worse. We are testing a new medicine called RVU120. We will give it on its own or together with another drug called everolimus (also known as Votubia or Certican). The main aim is to find the safest dose of RVU120, both by itself and when combined with everolimus. We also want to understand any side effects that might happen. Later on, we will look at how well the treatment shrinks the tumour and how long children stay well.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Instytut Pomnik Centrum Zdrowia Dziecka

Enrolment target

Start

23 Apr 2026

Medulloblastoma (recurrent or progressive)

What is this study about?

The MEDWAY study is a clinical trial exploring a new potential treatment for a specific type of brain tumour called medulloblastoma. This particular study focuses on children whose medulloblastoma has either come back after previous treatment or is continuing to grow and spread. These types of cancers are often difficult to treat, so finding new options is really important.

Researchers are investigating a new drug called RVU120. They want to see how it works both on its own and when combined with an existing medicine called everolimus. Everolimus is already used for some types of cancer and is known by brand names like Votubia or Certican. By combining these drugs, doctors hope to find a more effective way to fight the cancer cells.

This is a 'Phase I' study, which means it's one of the first times this new drug is being tested in people. The main goals are to find the right dose that is both safe and effective, and to understand any side effects. Later, if the treatment looks promising, more studies would be done to confirm how well it works long-term.

Key takeaways

This study is for children with medulloblastoma that has come back or is getting worse.
It's testing a new medicine called RVU120, alone or with everolimus.
The main aim is to find the safest dose and understand side effects.
This is an early-stage study, so the benefits are not yet fully known.
Close monitoring will be in place for all children taking part.

Who may be eligible?

This study is open to children who have been diagnosed with a specific type of brain tumour called medulloblastoma. This is particularly for those whose cancer has returned after treatment or has started to grow again.

There are no specific age limits; it's open to children of all ages who meet the other study requirements. Both boys and girls can take part.

Doctors will carefully check each child to make sure they are suitable for the study. This involves reviewing their medical history and performing certain tests to ensure the treatment is as safe as possible for them.

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.

My child has been diagnosed with medulloblastoma.
My child's medulloblastoma has come back or is progressing.
I understand this is a new type of medicine being tested.
My child is able to attend regular hospital visits for treatment and check-ups.

Answer every question to see your result.

What does participation involve?

If your child decides to take part in the MEDWAY study, they will receive the new medicine, RVU120, either on its own or together with everolimus. They will need to attend regular clinic visits where doctors and nurses will monitor their health closely. This will involve regular check-ups, blood tests, and scans to see how the treatment is working and to keep an eye on any side effects.

The study aims to find the right dose, so your child might start on a lower dose and it could be adjusted over time. These visits and tests will continue throughout the treatment period. There will also be follow-up appointments after treatment has finished to continue monitoring their health and well-being. The total duration of participation will vary depending on your child's response to the treatment.

Potential risks and benefits

Taking part in a new study always comes with potential benefits and risks. Your child might benefit from getting access to a new medicine that isn't widely available yet, which could help fight their cancer. However, this is a very early-stage study, so we don't yet know how effective RVU120 will be. As with any medicine, there's a chance of side effects, which could range from mild to serious. The doctors and nurses will monitor your child very carefully for any reactions. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What is medulloblastoma?

Medulloblastoma is a type of cancerous brain tumour that typically starts in the cerebellum, which is the back part of the brain.

What is a 'Phase I' study?

A Phase I study is the first step in testing a new medicine in people. Its main goal is to find a safe dose and see what side effects might happen.

What are RVU120 and everolimus?

RVU120 is a new medicine being tested. Everolimus is an existing medicine, sometimes called Votubia or Certican, that is used for some cancers and is being tested in combination with RVU120.

Will my child definitely get the new drug?

Yes, in this study, all children will receive RVU120, either on its own or combined with everolimus. There is no placebo group.

Can we stop participating if we change our mind?

Yes, you can withdraw your child from the study at any time, for any reason. Their regular medical care will not be affected.