A Trial of Durvalumab (MEDI 4736) in Combination With Extended Neoadjuvant Regimens in Rectal Cancer
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
PRIME-RT is an open label, multi-centre phase II randomised trial with 1:1 allocation between
arm A and arm B. The principal research question is whether the addition of durvalumab to
FOLFOX chemotherapy and radiation treatment (either SCRT or LCRT) in the neoadjuvant setting
for patients with locally advanced rectal cancer (LARC) improves rates of complete response.
The working hypothesis is that the use of radiation and cytotoxic chemotherapy may prime the
tumour immune microenvironment for treatment with immune checkpoint blockade. The main trial
will commence after completion of a safety run-in which will enrol at least three patients
per arm to test the safety and tolerability of the treatment combinations in each.
Phase:
Phase 2
Details
Lead Sponsor:
Liz-Anne Lewsley
Collaborators:
AstraZeneca NHS Greater Glasgow and Clyde University of Glasgow