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Study of Avelumab and Lenvatinib for Children with Central Nervous System Tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for children with Central Nervous System Tumors, which are cancers that occur in the brain or spinal cord. The study is testing a combination of two medications: Avelumab and Lenvatinib. Avelumab is a type of protein that helps the immune system fight cancer, while Lenvatinib is a chemical that blocks certain proteins that help cancer cells grow. The purpose of the study is to find out how safe and effective these medications are when used together in children.

The study is divided into two parts. In the first part, the focus is on determining the safest dose of the medications that can be given to children. In the second part, the study will look at how well the combination of Avelumab and Lenvatinib works in treating the tumors. Children participating in the study will receive the medications and be monitored closely by doctors to see how their bodies respond. Some children may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, doctors will check for any side effects and measure how the tumors respond to the treatment. The study aims to provide valuable information on the potential benefits and risks of using Avelumab and Lenvatinib together for treating Central Nervous System Tumors in children. This research could lead to new treatment options for young patients with these types of tumors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure adequate organ function and overall health status.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of avelumab and lenvatinib. Avelumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The specific dosage and frequency are determined based on the study protocol.

    Lenvatinib is provided in the form of hard capsules, taken orally. The dosage and frequency are also specified in the study protocol and may vary depending on individual response and tolerance.

  3. Step 3

    Dose escalation

    During the dose escalation phase, the safety and tolerability of the medications are closely monitored. The goal is to determine the most appropriate dose for further study. This involves regular check-ups and assessments to observe any side effects or adverse reactions.

  4. Step 4

    Dose expansion

    Once the recommended dose is established, the dose expansion phase begins. This phase focuses on evaluating the effectiveness of the treatment in controlling the disease. Regular imaging and clinical evaluations are conducted to assess the response to treatment.

  5. Step 5

    Follow-up

    After completing the treatment phase, a follow-up period is conducted to monitor long-term effects and overall survival. This includes periodic health assessments and imaging studies to track the disease status.

Who can join the trial?

15 criteria

  • Participants must be between 2 and 18 years old at the time of signing the consent form.
  • Girls who have started menstruating or are 10 years or older must have a negative pregnancy test before starting the study.
  • Participants who can have children must agree to either not have sexual activity or use two reliable birth control methods during the study and for at least 60 days after stopping the study treatments.
  • Participants must have a heart function test showing a fractional shortening of at least 30% or a left ventricular ejection fraction of at least 50% within 28 days before starting the study.
  • Participants with seizures can join if their seizures are well controlled and their medication dose is stable.
  • Participants must be able to follow the study rules and procedures.
  • Participants can be male or female. Female participants must not be pregnant or breastfeeding and must use a highly effective birth control method if they can have children. Male participants must agree not to donate sperm and either avoid activities that could lead to pregnancy or use birth control during the study and for at least 60 days after the last dose of study treatment.
  • Participants must have a confirmed diagnosis of a primary central nervous system (CNS) tumor. This means the tumor started in the brain or spinal cord. The tumor should be high-grade, which means it is more aggressive. Participants must have had prior radiotherapy and at least one previous treatment, except for certain types of tumors like diffuse midline glioma.
  • Participants must have measurable disease according to specific criteria on screening scans.
  • Participants must have a performance status score of at least 50, which measures their ability to perform daily activities. This is based on age: Lansky score for those 16 years or younger, and Karnofsky score for those older than 16 years.
  • Participants must have adequate bone marrow function, which means having a certain level of blood cells: absolute neutrophil count of at least 1000/μL, platelet count of at least 100,000/mm³, and hemoglobin of at least 8 g/dL.
  • Participants must have adequate kidney function, shown by a serum creatinine level within a certain range or a creatinine clearance rate above 70 mL/minute.
  • Participants must have adequate liver function, shown by specific levels of bilirubin and liver enzymes (AST and ALT) within certain limits.
  • Participants must have a prothrombin time/international normalized ratio (INR) within a certain range, which measures blood clotting ability.
  • Participants must provide a sample of tumor tissue, either as a block or slides, for testing. The sample should be from the most recent biopsy and from an area that has not been treated with radiation.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides Central Nervous System Tumors cannot participate.
  • Individuals who have not recovered from previous treatments or surgeries are excluded.
  • Patients with severe heart problems are not eligible.
  • Those with uncontrolled high blood pressure cannot join the study.
  • Individuals with active infections, such as untreated bacterial or viral infections, are excluded.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients with a history of severe allergic reactions to similar medications are excluded.
  • Individuals with certain autoimmune diseases, where the immune system attacks the body, cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Individuals with a history of drug or alcohol abuse may be excluded.
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Investigated drugs

  • Avelumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping the body's immune system recognize and attack cancer cells. In this trial, avelumab is being tested to see if it can help treat children with primary central nervous system (CNS) tumors.

  • Lenvatinib

    is a medication that targets certain proteins in cancer cells, which can help stop the growth and spread of tumors. It is being used in this trial alongside avelumab to see if the combination is effective in treating primary CNS tumors in children.

What is already known about the treatment

  • Avelumab

    Avelumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its potential use in treating central nervous system tumors, particularly in children. Avelumab is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, which can help the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody and is part of the immunotherapy class of cancer treatments.

  • Lenvatinib

    Lenvatinib is taken orally in the form of capsules. It is under investigation in clinical trials for its effectiveness in treating central nervous system tumors in pediatric patients. Lenvatinib functions by inhibiting multiple receptor tyrosine kinases, which are involved in tumor growth and angiogenesis, thereby potentially slowing or stopping the growth of cancer cells. It is classified as a tyrosine kinase inhibitor and is used in targeted cancer therapy.

Investigated diseases

Central Nervous System Tumors – These are abnormal growths of cells that occur in the brain or spinal cord. They can be either benign, meaning non-cancerous, or malignant, which are cancerous. The progression of these tumors can vary widely; some grow slowly and may not cause symptoms for a long time, while others can grow rapidly and cause significant neurological issues. Symptoms depend on the tumor's location and size and may include headaches, seizures, or changes in behavior or cognitive function. As the tumor grows, it can put pressure on surrounding brain structures, leading to more pronounced symptoms. The exact cause of central nervous system tumors is often unknown, but genetic factors and exposure to certain environmental risks may play a role.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2024-512940-51-00Protocol codeMS100070_0087Estimated enrolment45 patientsSponsorMerck Healthcare KGaA

sourced from the EU Clinical Trials Register and site verification

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