Spots Global Cancer Trial Database for Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
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Trial Identification
Brief Title: Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
Official Title: Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors
Study ID: NCT05081180
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Washington University, Saint Louis, Missouri, United States
CHU Sainte-Justine, Montréal, , Canada
The Hospital for Sick Children, Toronto, , Canada
CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique, Angers Cedex 9, , France
Hôpital de la Timone, Marseille Cedex 05, , France
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris, Paris cedex 05, , France
Universitaetsklinikum Hamburg Eppendorf, Hamburg, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Contact Details
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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