Durvalumab and Tremelimumab for Pediatric Malignancies
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- STATUS
- Recruiting
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- End date
- Dec 22, 2023
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- participants needed
- 92
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- 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.
Description
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
Details
| Condition | Pediatric Cancer, Solid Tumor Pediatric, Hematological Malignancies |
|---|---|
| Treatment | Durvalumab / Tremelimumab Combination Therapy |
| Clinical Study Identifier | NCT03837899 |
| Sponsor | AstraZeneca |
| Last Modified on | 27 June 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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