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

A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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 metastatic pancreatic ductal adenocarcinoma (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.

Detailed description

This is a randomized, double-blind, multicenter two-arm, phase III study that has two parts: * Safety run-in part: An open-label safety run-in part will be conducted to confirm recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel. Up to approximately 10 participants will be enrolled at each dose level to achieve at least 6 evaluable participants; however, if the starting dose is not recommended and a lower dose level is tested, 10 additional participants will be enrolled. The decision to open the randomized part will be based on dose confirmation and available safety, relevant PK, and other relevant data from run-in part * Randomized part: Enrolled participants will be randomized to the two treatment arms. The study treatment will be administered as a 28-day treatment cycle. Participants will be treated until unacceptable toxicity, disease progression per RECIST 1.1, withdrawal of consent or any other condition of treatment discontinuation specified in the protocol. Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped. The trial was unblinded and study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.

Conditions

• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	NIS793	Concentrate for solution infusion (Liquid in Vial)
DRUG	Nab-paclitaxel	Per locally approved formulation
DRUG	Gemcitabine	Per locally approved formulation
DRUG	Placebo	Dextrose 5% in water (D5W) solution for infusion

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-08-13
• Completion: 2024-08-13
• First posted: 2021-06-23
• Last updated: 2025-01-07

Locations

113 sites across 27 countries: United States, Australia, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Norway, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study