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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

December 3, 2021

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Central Nervous System Tumors
Interventions
DRUG

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.

DRUG

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.

Trial Locations (9)

Unknown

CHU Sainte-Justine, Montreal

The Hospital for Sick Children, Toronto

CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique, Angers

Hôpital de la Timone, Marseille

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

Universitaetsklinikum Hamburg Eppendorf, Hamburg

Universitaetsklinikum Muenster, Münster

Seoul National University Hospital, Seoul

Severance Hospital, Yonsei University Health System, Seoul

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT05081180 - Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors | Biotech Hunter | Biotech Hunter