drugset / Trial / NCT04935359

Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

NCT04935359

Phase 3 Completed 511 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aimed to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel could reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

Timeline

Start
2021-09-30
Primary completion
2024-08-13
Completion
2024-08-13

Drugs

EvaluationDrugModalityDoseRoute
Subject NISEVOKITUG Monoclonal antibody 2100 mg Intravenous
Background Gemcitabine Small molecule 1000 mg/m2
Background Paclitaxel Small molecule 125 mg/m2