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

ClinicalTrials.gov Identifier: NCT04935359

Novartis Reference Number: CNIS793B12301

Last Update: May 03, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Metastatic Pancreatic Ductal Adenocarcinoma
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Sep 30, 2021
Completion date 
Jan 01, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

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

Eligibility Criteria

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.

Main Exclusion Criteria:

Applicable for both Safety run-in and Randomized part

Previous systemic anti-cancer treatment for metastatic PDAC
Pancreatic neuroendocrine, acinar, or islet 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)

Study Locations

United States
Highlands Oncology Group
Recruiting
Fayetteville, 72703 - Arkansas
Contact: London Hall (479-587-1700) - [email protected] - Joseph T. Beck
United States
US Oncology Research, Dallas
Recruiting
Dallas, 75204 - Texas
Contact: Penny R Watkins - [email protected] - Pavan Kancharla
United States
Australia
Novartis Investigative Site
Recruiting
Perth,
Western Australia
Australia
Belgium
Novartis Investigative Site
Recruiting
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
Recruiting
Bonheiden, 2820
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60488
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20249
-
Germany
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 9112001
-
Israel
Japan
Novartis Investigative Site
Recruiting
Kashiwa, 277 8577
Chiba
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Russian Federation
Novartis Investigative Site
Recruiting
Pushkin Saint Petersburg, 196603
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Santiago de Compostela, 15706
Galicia
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]