Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden

Inclusion Criteria: * 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. * Radiologically confirmed stage 4 mPDA, with measurable disease * Received no more than 1 prior systemic therapy regimen for unresectable (stage 3 or 4) PDA is allowed * Measurable disease which has not been irradiated in prior radiotherapy * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * Life expectancy \>12 weeks from the date of screening assessment * Adequate bone marrow function: * Absolute neutrophil count (ANC) ≥1.5 x 109 /L * Haemoglobin (Hb) ≥ 90 g/L * Platelets ≥100 x 109 /L * Adequate liver function: * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 x upper limit of normal range (ULN), or \