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 and expand in a second phase to test the efficacy of these drugs
once this dose is determined.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03837899.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Name Not Available
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 PK 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 (ADA) levels, and
anti-tumor activity. The results from this trial will form the basis for decisions for
potential future pediatric studies
Lead OrganizationAstraZeneca Pharmaceuticals LP