At a glance
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Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination With Tremelimumab in Pediatric Patients With Advanced Solid Tumors and Hematological Malignancies.
In Brief
A Phase 2 clinical trial evaluating Durvalumab / Tremelimumab Combination Therapy for Pediatric Cancer and 2 related conditions. Active but no longer recruiting, targeting 50 participants across 19 sites in 7 countries.
Detailed Summary
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 Details
Timeline
Interventions
Starting dose: durvalumab: 20mg/kg tremelimumab: 1mg/kg at cycles 2 to 5 only co-administered with durvalumab. The Recommended Phase 2 dose will be used for the dose expansion phase.