Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT04935359

PHASE3

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

511

Start Date

2021-09-30

Completion Date

2024-08-13

Last Updated

2026-05-19

Healthy Volunteers

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

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

Key Inclusion Criteria: Applicable for both Safety run-in and Randomized part * Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery * Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Adequate organ function (assessed by central laboratory for eligibility) * Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia. Key Main Exclusion Criteria: Applicable for both Safety run-in and Randomized part * Previous systemic anti-cancer treatment for metastatic PDAC * Pancreatic neuroendocrine (islet) or acinar tumors * Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening). * Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment. * Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed \> 2 weeks prior to start of study treatment). * Impaired cardiac function or clinically significant cardio-vascular disease * Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment. * Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding. * Serious non-healing wounds. * Pregnant or breast-feeding women * Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated * Pre-existing peripheral neuropathy \> grade 1 (CTCAE v5.0) Other Inclusion/Exclusion criteria may apply.

Locations (113)

Highlands Oncology Group

Fayetteville, Arkansas, United States

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

Novartis Investigative Site

Dalian, Liaoning, China

Novartis Investigative Site

Jining, Shandong, China

Novartis Investigative Site

Xian, Shanxi, China

Novartis Investigative Site

Chengdu, Sichuan, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Hradec Králové, Czechia

Novartis Investigative Site

Nový Jičín, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Helsinki, Finland

Novartis Investigative Site

Tampere, Finland

Novartis Investigative Site

Nice, Alpes Maritimes, France

Novartis Investigative Site

Avignon, France

Novartis Investigative Site

Besançon, France

Novartis Investigative Site

Créteil, France

Novartis Investigative Site

Lyon 08, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bochum, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Ulm, Germany

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Verona, VR, Italy

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Osaka, Osaka, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Koto Ku, Tokyo, Japan

Novartis Investigative Site

Utrecht, Netherlands

Novartis Investigative Site

Nordbyhagen, Oslo, Norway

Novartis Investigative Site

Oslo, Norway

Novartis Investigative Site

Omsk, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Banská Bystrica, Slovakia

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Košice, Slovakia

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Malmö, Sweden

Novartis Investigative Site

Umeå, Sweden

Novartis Investigative Site

Bellinzona, Switzerland

Novartis Investigative Site

Geneva, Switzerland

And 13 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (113)