Avelumab Dose Selection for Clinical Studies in Pediatric Patients with Solid Tumors.

ABSTRACT:

Background and objective

A phase I/II trial evaluated the safety, antitumor activity, and pharmacokinetics of avelumab (anti-PD-L1 antibody) in pediatric patients with refractory/relapsed solid tumors (NCT03451825). This study aimed to inform avelumab dose selection in pediatric populations using population pharmacokinetic modeling and simulations.

Methods

Patients aged < 18 years with refractory/relapsed solid tumors enrolled in phase I received avelumab 10 or 20 mg/kg intravenously every 2 weeks. A pediatric population pharmacokinetic model was developed via the frequentist prior approach.

Results

Pharmacokinetic parameters from 21 patients who received avelumab 10 mg/kg (n = 6) or 20 mg/kg (n = 15) were analyzed. Patients had a wide range of weights and ages (media

SUBMITTER: Vugmeyster Y 

PROVIDER: S-EPMC9287219 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature