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Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
Sponsor: 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.
Official title: Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2021-12-03
Completion Date
2026-09-30
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Avelumab
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.
Lenvatinib
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.
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