Neoplasms

Nervous System Diseases

All Conditions

Central Nervous System Neoplasms

Nervous System Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Avelumab

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Participants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive intravenous infusion at a flat dose or weight based dose of Avelumab, every 2 weeks (Q2W) until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when Maximum tolerated dose (MTD) and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE in Part 2 until progression, unacceptable toxicity, or withdrawal of consent.

Participants with primary CNS malignancies who have received at least 1 prior therapy will be enrolled into Dose Escalation Part 1 and will receive daily oral escalated dose level of Lenvatinib until progression, unacceptable toxicity, or withdrawal of consent. Enrollment into part 1 of the study will end when MTD and/or a safe Recommended Dose for Expansion (RDE) for the expansion cohort is determined. Participants with defined CNS tumors will be enrolled into Dose Expansion Part 2 and will receive RDE of Lenvatinib in Part 2 until progression, unacceptable toxicity, or withdrawal of consent.

US Medical Information

Communication Center

Sebastien Perreault

Eric Bouffet

Emilie De Carli

Nicolas André

François Doz

Uwe Kordes

Kornelius Kerl

Hyoung Jin Kang

Jung Woo Han

Medical Responsible

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.

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

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors	NCT05081180	Central Nervous...	Avelumab Lenvatinib	2 Years - 18 Years	EMD Serono
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors	NCT05081180	Central Nervous...	Avelumab Lenvatinib	2 Years - 18 Years	EMD Serono

Spots Global Cancer Trial Database for pediatric cns tumors