drugset / Trial / NCT05081180
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
Phase 1
Active not recruiting
17 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-12-03
- Primary completion
- 2026-02-11
- Completion
- 2026-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | — | Intravenous |
| Subject | Lenvatinib | Small molecule | — | Oral |