A Trial of Radiotherapy and Durvalumab in DLBCL and FL

Summary

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.

Timeline

Start

2018-11-01

Primary completion

2023-04-05

Completion

2024-04-08

Publications

• Hawkes EA, Palmer JB, Khor R, Lee ST, Burgess M, Law SC, Gandhi MK, Chong G, Shortt J, Chowdhury R, Swain F, Churilov L, MacManus M, Smith C, Scott FE, Martynchyk A, Barraclough A, Manos K, Scott AM, Keane C. T-cell dysregulation informs radiotherapy-immunotherapy response in B-cell lymphoma: results from a phase 1 trial. Blood Adv. 2025 Oct 28;9(20):5263-5273. doi: 10.1182/bloodadvances.2025016505.

Drugs

Indications