PRIMUS-001: An adaptive phase II study of FOLFOX-A (FOLFOX and nab-paclitaxel) versus AG (nab-paclitaxel and gemcitabine) in patients with metastatic pancreatic cancer, with integrated biomarker evaluation (ISRCTN75002153) – Part of Precision-Panc

TPS4158Background: Platinum-containing regimens (e.g. FOLFIRINOX) have shown survival benefit for pancreatic cancer (PC), with some “exceptional responders”; biomarkers (BM) of response are not well defined. Tumors with mutations in BRCA1/2 and other Fanconi Anemia genes, are preferentially sensitive to DNA-damaging agents (e.g. platinum) through synthetic lethality mechanisms, as they are defective in DNA damage response (DDR). We have shown that DDR deficiency may be present in 20% of PC. PRIMUS-001 aims to exploit defective DDR as a therapeutic vulnerability, with integrated study of BM of DNA-damaging agent response. Methods: PRIMUS-001 will enroll patients who are profiled molecularly using Precision-Panc NGS Diagnostic (BM via bespoke clinical grade assay). It is a multicentre, randomized (1:1), open-label, phase II trial comparing FOLFOX-A (nab-paclitaxel 150mg/m2 IV, oxaliplatin 85mg/m2, folinic acid 350mg flat dose, fluorouracil infusion 2400mg/m2 continuous IV infusion) vs AG (nab-paclitaxel 125...