17
Participants
Start Date
December 3, 2021
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2026
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.
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
Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY