Durvalumab (MEDI 4736) in combination with extended neoadjuvant regimens in rectal cancer: a study protocol of a randomised phase II trial (PRIME-RT).
Catherine R HannaSean Michael O'CathailJanet S GrahamMark SaundersLeslie M SamuelMark HarrisonLynsey DevlinJoanne EdwardsDaniel R GayaCaroline A KellyLiz-Anne LewsleyNoori MakaPaula MorrisonLouise DinnettSusan DillonJacqueline GourlayJonathan J PlattFiona ThomsonRichard A AdamsCampbell Stuart RoxburghPublished in: Radiation oncology (London, England) (2021)
PRIME-RT will explore if adding immunotherapy to neoadjuvant radiotherapy and chemotherapy for patients with LARC can prime the tumour microenvironment to improve complete response rates and stoma free survival. Sequential biopsies are a key component within the trial design that will provide new knowledge on how the tumour microenvironment changes at different time-points in response to multi-modality treatment. This expectation is that the trial will provide information to test this treatment within a large phase clinical trial. Trial registration Clinicaltrials.gov NCT04621370 (Registered 9th Nov 2020) EudraCT number 2019-001471-36 (Registered 6th Nov 2020).