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Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors

NCT05081180•EMD Serono Research & Development Institute, Inc.

Summary

This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended Avelumab and Lenvatinib dose for expansion. Dose Expansion Part 2 will assess the efficacy of Avelumab in combination with Lenvatinib by Progression-free Survival in participants with pre-defined primary central nervous system (CNS) tumors.

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with histologically confirmed diagnosis of primary CNS malignancy as follows: a) Primary CNS tumors: the tumor should be considered high-grade histologically; prior radiotherapy is allowed; participants must have progressed after at least 1 prior systemic therapy, except for those with diffuse midline glioma with or without the H3 K27M mutation. b) Specific for participants with diffuse midline glioma with or without the H3 K27M mutation: prior radiotherapy is allowed; no more than 1 prior systemic therapy is allowed; participants with diffuse midline glioma with or without the H3 K27M mutation who have not received prior systemic therapy but have prior radiotherapy only are allowed to enroll
•On screening scans, measurable disease by RANO criteria
•Participants must have a Lansky performance status \>= 50 for age \<= 16 years or Karnofsky performance status \>= 50 for age \> 16 years at Screening
•Participants who have received major surgery (including but not limited to neurosurgical resection, brain biopsy, or radiation to the primary brain tumor) within 28 days prior to the first dose of study interventions
•Participants with history of intracranial hemorrhage/spinal cord hemorrhage within 28 days prior to the first dose of study interventions

Exclusion Criteria

•Participants with low-grade gliomas, for example but not limited to, subependymal giant cell astrocytoma, pilocytic astrocytoma and World Health organization (WHO) Grade 1 tumors
•Participants demonstrating evidence of worsening of neurologic deficit within 1 week prior to initiation of study interventions
•Participants with bulky tumor, defined as: a) Tumor with any evidence of uncal herniation or midline shift; b) Tumor with a diameter of \> 4 centimeters (cm) in 1 dimension on T2/ fluid-attenuated inversion recovery (FLAIR) images; c) Tumor that in the opinion of the Investigator shows significant mass effect

Locations (9)

CHU Sainte-Justine

Montreal, Canada

The Hospital for Sick Children

Toronto, Canada

CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique

Angers, France

Hôpital de la Timone

Marseille, France

Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

Paris, France

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Muenster

Münster, Germany

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Key Dates

Start Date

December 3, 2021

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

January 23, 2026

Enrollment

ACTUAL participants

Conditions

Central Nervous System Tumors

Interventions

Avelumab

DRUG

Lenvatinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors

Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma

Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma

Study of Stored Tumor Samples in Young Patients With Brain Tumors