A randomized, three-arm, double-blind, placebo-controlled, phase III study, comparing NIS793 with or without spartalizumab in combination with gemcitabine and nab-paclitaxel versus matching placebos combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line mPDAC. This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes. A safety run-in part will be conducted before opening a randomized part to confirm the recommended phase 3 dose (RP3D) of NIS793 in combination with SOC anti-cancer therapy.