A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden
Aged ≥ 18 years old
Written informed consent
Histologically or cytologically confirmed PDA
Confirmation that the PDA has TMB >4 mutations/Mb, or dMMR gene mutation, or MSI-H by IHC. TMB status and dMMR can be obtained from either tissue, or blood.
Patients with resectable or locally advanced PDA
Other invasive malignancies diagnosed within the last 2 years which have not been treated with curative intent
Prior immune checkpoint inhibitors or PARP inhibitors. This includes any prior therapy with an anti-PD-1, or anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g, CTLA-4, OX 40, CD137)
Requirement for non-physiological dose of daily oral steroids, or regular use of any other immunosuppressive agents; prednisolone dose of < 10mg (or equivalent steroid dose) is allowed. Use of inhaled or topical steroids is allowed.
Cambridge University Hospitals NHS Foundation Trust
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator