Avelumab + Lenvatinib for Brain Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for Avelumab and Lenvatinib in humans?
How is the drug Avelumab + Lenvatinib unique for treating brain cancer?
Avelumab + Lenvatinib is unique because it combines an immune checkpoint inhibitor (Avelumab) with a multikinase inhibitor (Lenvatinib) that targets multiple pathways involved in tumor growth and blood vessel formation, potentially enhancing the immune system's ability to fight cancer. This combination approach is novel for brain cancer, where standard treatments are limited.34678
Research Team
Medical Responsible
Principal Investigator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Eligibility Criteria
This trial is for children with confirmed primary CNS tumors who meet specific criteria based on tumor type and previous treatments. They must have measurable disease, be able to perform daily activities at a certain level (Lansky or Karnofsky performance status >= 50), and not have had major surgery or intracranial hemorrhage recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation Part 1
Evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended dose for expansion
Dose Expansion Part 2
Assess the efficacy of Avelumab in combination with Lenvatinib by Progression-free Survival in participants with pre-defined primary CNS tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Avelumab
- Lenvatinib
Avelumab is already approved in European Union, United States, Japan for the following indications:
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
Miguel Fernández Alcalde
EMD Serono Research & Development Institute, Inc.
Chief Executive Officer
Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School
Danny Bar-Zohar
EMD Serono Research & Development Institute, Inc.
Chief Medical Officer since 2022
MD
Merck KGaA, Darmstadt, Germany
Industry Sponsor
Danny Bar-Zohar
Merck KGaA, Darmstadt, Germany
Chief Medical Officer since 2022
MD
Belén Garijo
Merck KGaA, Darmstadt, Germany
Chief Executive Officer since 2021
MD