Title: Durvalumab and Tremelimumab for Pediatric Malignancies
Principle Investigator: Dana Ghiorghiu, MD, PhD, AstraZeneca Global Medicines Development, Academy House
Description: The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers. After phase 1, the study will expand in a second phase to test the efficacy of these drugs at the determine dosage. This is a first time in pediatrics study primarily designed to evaluate the safety and tolerability of durvalumab and durvalumab in combination with tremelimumab at increasing doses in pediatric patients with advanced solid malignancies and hematological malignancies (including lymphomas) and for whom no standard of care treatments exist. Although treatment efficacy is not a primary objective of this study given its early phase nature, the patients screened for this study have no curative options and this study offers the potential of some benefit. The study will also characterize the pharmacokinetics of durvalumab and durvalumab in combination with tremelimumab in children and adolescents and explore potential biological activity and immunogenicity by assessing pharmacodynamics, anti-drug antibody levels, and anti-tumor activity. The results from this trial will form the basis for decisions for potential future pediatric studies.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03837899.
Status: This study is open and recruiting patients as of May 27, 2019.
This study is sponsored by AstraZeneca.
Clinicaltrials.gov. Durvalumab and Tremelimumab for Pediatric Malignancies. NCT03837899. https://clinicaltrials.gov/ct2/show/NCT03837899. Accessed June 24, 2019.