A Trial of Radiotherapy and Durvalumab in DLBCL and FL
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Austin Health
Collaborators:
AstraZeneca Olivia Newton-John Cancer Research Institute