CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
NIS793 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04935359
NCT04935359Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Jun 23, 2021·Updated May 19, 2026

In Brief

A Phase 3 clinical trial evaluating NIS793, Nab-paclitaxel, and 2 other interventions for Metastatic Pancreatic Ductal Adenocarcinoma. Completed, enrolled 511 participants across 113 sites in 27 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Ductal Adenocarcinoma
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJun 23, 2021
Enrollment StartSep 30, 2021
Primary CompletionAug 13, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.0 years ago

Interventions

NIS793drug

Concentrate for solution infusion (Liquid in Vial)

Nab-paclitaxeldrug

Per locally approved formulation

Gemcitabinedrug

Per locally approved formulation

Placebodrug

Dextrose 5% in water (D5W) solution for infusion