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
Completed · Phase 3 · Has a placebo group
Conditions studied: Metastatic Pancreatic Ductal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT04935359
- Run by
- Novartis Pharmaceuticals
- People needed
- 511
- Starts
- 2021-09-30
- Expected to finish
- 2024-08-13
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California LA — Los Angeles, California, United States
- AdventHealth — Orlando, Florida, United States
- Fort Wayne Medical Oncology Hematology Inc — Fort Wayne, Indiana, United States
- NYU Clinical Cancer Center — New York, New York, United States
- US Oncology Research Dallas — Dallas, Texas, United States
- Houston Methodist Hospital — Houston, Texas, United States
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Novartis Investigative Site — Adelaide, South Australia, Australia
- Novartis Investigative Site — Perth, Western Australia, Australia
- Novartis Investigative Site — Bonheiden, Belgium
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Edegem, Belgium
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Brasília, Federal District, Brazil
- Novartis Investigative Site — Ijuí, Rio Grande do Sul, Brazil
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — Brampton, Ontario, Canada
- Novartis Investigative Site — Cambridge, Ontario, Canada
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Guangzhou, Guangdong, China
- Novartis Investigative Site — Harbin, Heilongjiang, China
- Novartis Investigative Site — Nanjing, Jiangsu, China
- Highlands Oncology Group — Fayetteville, Arkansas, United States
Full record on ClinicalTrials.gov
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