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
NCT ID: NCT04935359
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2021-09-30
2024-08-13
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Safety run-in part: NIS793+gemcitabine+nab-paclitaxel
In the safety run-in part, participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel.
NIS793
Concentrate for solution infusion (Liquid in Vial)
Nab-paclitaxel
Per locally approved formulation
Gemcitabine
Per locally approved formulation
Randomized part: NIS793+gemcitabine+nab-paclitaxel
Participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel
Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.
NIS793
Concentrate for solution infusion (Liquid in Vial)
Nab-paclitaxel
Per locally approved formulation
Gemcitabine
Per locally approved formulation
Placebo
Dextrose 5% in water (D5W) solution for infusion
Randomized part: placebo+gemcitabine+nab-paclitaxel
Participants will receive a combination of placebo, gemcitabine and nab-paclitaxel
Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.
Nab-paclitaxel
Per locally approved formulation
Gemcitabine
Per locally approved formulation
Placebo
Dextrose 5% in water (D5W) solution for infusion
Interventions
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NIS793
Concentrate for solution infusion (Liquid in Vial)
Nab-paclitaxel
Per locally approved formulation
Gemcitabine
Per locally approved formulation
Placebo
Dextrose 5% in water (D5W) solution for infusion
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
University of California LA
Los Angeles, California, United States
Advent Health Cancer Institute
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
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Perth, Western Australia, Australia
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Bonheiden, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Brasília, Federal District, Brazil
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Ijuí, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Toronto, Ontario, Canada
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Guangzhou, Guangdong, China
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Harbin, Heilongjiang, China
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Nanjing, Jiangsu, China
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Dalian, Liaoning, China
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Jining, Shandong, China
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Xian, Shanxi, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Brno, Czech Republic, Czechia
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Nový Jičín, Czech Republic, Czechia
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Hradec Králové, CZE, Czechia
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Prague, , Czechia
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Helsinki, , Finland
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Tampere, , Finland
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Nice, Alpes Maritimes, France
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Avignon, , France
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Besançon, , France
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Créteil, , France
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Lyon 08, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Berlin, , Germany
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Bochum, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Halle S, , Germany
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Hamburg, , Germany
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Ulm, , Germany
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Jerusalem, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Florence, FI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Verona, VR, Italy
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Nagoya, Aichi-ken, Japan
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Kashiwa, Chiba, Japan
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Yokohama, Kanagawa, Japan
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Osaka, Osaka, Japan
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Chuo Ku, Tokyo, Japan
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Koto Ku, Tokyo, Japan
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Utrecht, , Netherlands
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Nordbyhagen, Oslo County, Norway
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Oslo, , Norway
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Omsk, , Russia
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Pushkin Saint Petersburg, , Russia
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Singapore, , Singapore
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Bratislava, Slovak Republic, Slovakia
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Banská Bystrica, , Slovakia
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Košice, , Slovakia
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Seoul, Seocho Gu, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Malmo, , Sweden
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Umeå, , Sweden
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Bellinzona, , Switzerland
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Geneva, , Switzerland
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Sankt Gallen, , Switzerland
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Sutton, Surrey, United Kingdom
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Cambridge, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
Countries
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Other Identifiers
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2021-000591-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNIS793B12301
Identifier Type: -
Identifier Source: org_study_id
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