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Durvalumab and Tremelimumab for Pediatric Malignancies
Sponsor: AstraZeneca
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.
Official title: 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.
Key Details
Gender
All
Age Range
0 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2019-03-07
Completion Date
2024-12-30
Last Updated
2024-10-29
Healthy Volunteers
No
Interventions
Durvalumab / Tremelimumab Combination Therapy
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.
Locations (19)
Research Site
Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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New Hyde Park, New York, United States
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Oklahoma City, Oklahoma, United States
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Charleston, South Carolina, United States
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Lille, France
Research Site
Marseille, France
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Paris, France
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Cologne, Germany
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Genova, Italy
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Milan, Italy
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Rome, Italy
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Torino, Italy
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Utrecht, Netherlands
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Barcelona, Spain
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Madrid, Spain
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Leeds, United Kingdom
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London, United Kingdom
Research Site
Sutton, United Kingdom