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| Diagnosis | Central Nervous System (CNS) Tumours | Study Status | Open |
| Phase | I |
| Age | 2 Years to 18 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Avelumab (Given through IV Infusion, every 2 weeks)
Drug: Lenvatinib (Given orally, daily) |
| Last Posted Update | 2022-04-25 |
| ClinicalTrials.gov # | NCT05081180 |
International Sponsor
EMD Serono Research & Development Institute, Inc.
Merck KGaAPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Ute Bartels
CHU Ste. Justine - Dr. Sebastien Perreault Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Study Description
In this study, researchers are trying to learn more about the safety of the combination of study medicines Avelumab and Lenvatinib, and how well they work for children and young people with central nervous system tumours where previous treatment have not worked.
If you/your child participate in this study, you/they will be asked to join one of the two parts.
Part 1 will help us learn the best dose of the drug to take, and in Part 2, we will use the information obtained in Part 1 to continue to give the study drug and monitor how it is working.
Inclusion Criteria
- Patients must have a confirmed diagnosis of a high-grade brain tumour
- Patients must be between the ages of 2-18 years old
- Patients must have a cancer that has come back (relapsed) after a previous treatment
- Patients must be able to walk and do routine activities for more than half of their normal waking hours
- Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)
Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.
