CNIS793B12301 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-paclitax

NCT04935359

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)

Associated Conditions

Pancreatic Cancer

Principal Investigator

Sponsor

Novartis

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.