Single-arm, multicenter Phase I/Ib study of avelumab + lenvatinib in children with primary CNS tumors
This clinical trial looks at a new combination of two cancer medicines for children and young people with primary central nervous system (brain or spinal cord) tumours. The medicines tested are avelumab, given as a drip into a vein, and lenvatinib, taken as capsules by mouth. Because this is an early-stage (Phase 1) trial, the main goal is to find safe doses for younger patients and monitor any side effects carefully. Avelumab works by helping the child's immune system recognise and attack cancer cells. Lenvatinib works by blocking signals that help tumours grow new blood vessels. In the first part of the study, doctors test different doses to make sure the combination is safe. In the second part, they observe how well the treatment helps control the tumour and keep it from growing. Doctors will monitor all participants closely throughout.
At a glance
What is this study about?
Primary central nervous system (CNS) tumours are cancers that start in the brain or spinal cord. When standard therapies do not work well enough or when a tumour returns after treatment, doctors look for new options. This clinical trial is testing whether combining two modern cancer medicines can help children and young people facing these difficult conditions.
The two medicines in this study work in different ways to tackle cancer. Lenvatinib is a targeted therapy designed to block the blood supply that tumours need to survive and multiply. Avelumab is an immunotherapy, a type of medicine that helps the body's natural immune defences recognise and fight tumour cells. Researchers hope that combining these two treatments will be more effective than using either drug on its own.
Because this is an early-stage study (Phase 1/1b), safety is the top priority. The first part of the trial works out the best and safest dose for children. Once doctors confirm a safe dose, more patients can join to help researchers see whether the treatment helps shrink tumours or keep them stable for longer.
Key takeaways
- Tests a combination of two targeted cancer drugs, avelumab and lenvatinib, in children with brain tumours.
- Mainly focuses on finding safe doses and checking for side effects in young patients.
- Combines an immune-boosting medicine with a drug that cuts off tumour blood supply.
- Involves daily capsules at home and regular hospital visits for drips, scans, and blood tests.
- Participation is completely voluntary and will not affect standard NHS care if you choose not to take part.
Who may be eligible?
This trial is for children and young people diagnosed with a primary tumour of the central nervous system (the brain or spinal cord). Both boys and girls can take part.
Generally, early-stage trials like this are designed for patients whose tumour has come back after treatment, or has continued to grow despite standard therapies. Children must also be reasonably well in their day-to-day life and have blood, liver, and kidney test results within acceptable safety levels.
Children may not be able to join if they have had severe allergic reactions to similar drugs in the past, or if they have other serious health problems that could make taking part unsafe. The hospital study team will review each child's medical history to check if the trial is right 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.
- Diagnosed with a primary brain or spinal cord tumour
- Tumour has returned or not responded to standard treatments
- Able to attend regular hospital visits for treatments and tests
- Able to take oral capsules or medicine by mouth
- Not currently taking another experimental cancer therapy
What does participation involve?
Taking part in this study involves receiving two different medicines. Lenvatinib is taken by mouth every day as capsules, while avelumab is given as a liquid drip directly into a vein during hospital visits, usually every few weeks.
Children will need regular hospital appointments for monitoring. These visits will involve physical examinations, blood and urine tests, and MRI or CT scans to see how the tumour is responding. The doctors will also take small blood samples to check how the medicines are handled by the body. Treatment usually continues for as long as it is helping and side effects remain manageable. Afterwards, the study team will carry out regular follow-up checks to monitor the child's long-term health.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedGermany
Common questions
What is the main goal of this trial?
The main goal is to find the safest dose of avelumab and lenvatinib for children and to see if the combination helps slow down tumour growth.
How are the medicines given?
Lenvatinib is swallowed as capsules every day at home. Avelumab is given through a drip into a vein at the hospital, usually once every few weeks.
Can my child leave the study if we change our minds?
Yes. You can leave the trial at any time for any reason, and your child's standard NHS care will continue as normal.
Will taking part cost anything?
No, the trial medicines and related tests are provided free of charge through the hospital.
Can my child take other cancer treatments during the study?
No, other cancer treatments are not allowed while taking part, but the study team will discuss this fully before you make any decisions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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