Title: Durvalumab and tremelimumab for pediatric malignancies
Principal Investigator: Ashok Gupta, MD, PhD, of AstraZeneca
Description: Researchers are conducting a phase 1/2 trial to evaluate the safety and efficacy of durvalumab plus tremelimumab in pediatric patients with advanced solid tumors or lymphoma.
In the dose-finding part of this study, researchers will determine the recommended phase 2 dose of durvalumab and tremelimumab. In the dose-expansion part of the study, the researchers will assess the efficacy and safety of the recommended dose.
In both parts of the study, patients will receive durvalumab and tremelimumab intravenously every 4 weeks. Tremelimumab will only be given with durvalumab for cycles 1 to 4, but an additional 4 doses may be added when a patient experiences disease progression.
Primary outcome measures include the recommended phase 2 dose, safety and tolerability, and the objective response rate. The secondary outcome is pharmacokinetics.
To be eligible for this study, patients must be 17 years of age or younger. They must have a solid tumor malignancy (but not a primary central nervous system tumor), primary mediastinal B-cell lymphoma, or anaplastic large-cell lymphoma that has progressed or is refractory to standard therapies or for which no standard therapy exists. For a full list of eligibility criteria, please see the reference.
This study is sponsored by AstraZeneca.
ClinicalTrials.gov. Durvalumab and tremelimumab for pediatric malignancies. NCT03837899. Accessed July 20, 2022.