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Open-label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma

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Trial Profile

Open-label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 08 Jul 2024

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At a glance

  • Drugs Avelumab (Primary)
  • Indications Astrocytoma; CNS cancer; Lymphoma; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors EMD Serono Research & Development Institute; Merck KGaA
  • Most Recent Events

    • 24 Jun 2024 Status changed from completed to discontinued. (Based on the limited activity observed with avelumab monotherapy in the pediatric population,the Phase II study part was cancelled.)
    • 01 Oct 2022 Results (n=21; data cutoff date: 27 Jul 2021) reporting dose-escalation data published in the Cancer Immunology Immunotherapy
    • 29 Apr 2022 Patients from this study were used to evaluate the pharmacokinetic modeling simulations was developed for dose selection, published in the Clinical Pharmacokinetics
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