Clinical Trial

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

Terminated Phase 1
View on ClinicalTrials.gov →
Why the trial stopped
The study was stopped due to a lack of clear evidence of anti-tumor activity with the combination treatment in the participants treated.
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.
Protocol Amendment History 4 changes
critical Trial terminated 2026-07-30
critical Trial terminated: The study was stopped due to a lack of clear evidence of anti-tumor activity with the combination treatment in the part... 2026-07-30
notable Primary completion moved earlier: 2026-09-30 -> 2026-02-11 2026-05-02
minor Completion moved earlier: 2026-09-30 -> 2026-05-29 2026-05-02
Trial Details
NCT Number NCT05081180
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Central Nervous System Tumors
Enrollment 17 participants
Start Date 2021-12-03
Primary Completion 2026-02-11 (estimated)
Study Completion 2026-06-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-29