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A Trial of Radiotherapy and Durvalumab in DLBCL and FL

Austin Health · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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diffuse-large-b-cell-lymphomafollicular-lymphoma
The primary objective for this study is to determine the safety profile of radiotherapy and durvalumab, a PD-L1 inhibitor. Primary endpoint: Toxicity, drug pharmacokinetics (PK), maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of simultaneous radiotherapy plus durvalumab in patients with relapsed or refractory DLBCL or FL. Secondary endpoints: * ORR * Progression-free survival * Overall survival Exploratory endpoints include description of biological effects of combination radiotherapy plus durvalumab (Imaging results, immune function, PK and PD-see 'research methodologies') and in the PET-Sub-Study, biodistribution of 89Zr Durvalumab and 89Zr-IAB22M2C.
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