Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
NCT ID: NCT04390763
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
164 participants
INTERVENTIONAL
2020-10-16
2024-05-02
Brief Summary
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Detailed Description
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The study started with a Safety Run-in to assess the safety and tolerability of NIS793 in combination with spartalizumab and standard of care (SOC) gemcitabine/nab-paclitaxel. Doses defined for each study treatment, as part of this quadruplet were administered in the Randomized part in the quadruplet/triplet/doublet-based treatment arms.
The Randomized part opened after the Safety Run-in had completed. Participants were randomized in a 1:1:1 ratio to one of the three treatment arms:
* Arm 1: NIS793 with spartalizumab and gemcitabine/nab-paclitaxel
* Arm 2: NIS793 with gemcitabine/nab-paclitaxel
* Arm 3: gemcitabine/nab-paclitaxel
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Safety Run-in
Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel
NIS793
anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.
Spartalizumab
anti-PD-1 antibody. spartalizumab 400 mg every 4 weeks by i.v. infusion.
gemcitabine
SOC chemotherapy. Gemcitabine (1000 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
nab-paclitaxel
SOC chemotherapy. Nab-paclitaxel (125 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
Randomized Arm 1
Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel
NIS793
anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.
Spartalizumab
anti-PD-1 antibody. spartalizumab 400 mg every 4 weeks by i.v. infusion.
gemcitabine
SOC chemotherapy. Gemcitabine (1000 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
nab-paclitaxel
SOC chemotherapy. Nab-paclitaxel (125 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
Randomized Arm 2
Combination of NIS793 + gemcitabine + nab-paclitaxel
NIS793
anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.
gemcitabine
SOC chemotherapy. Gemcitabine (1000 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
nab-paclitaxel
SOC chemotherapy. Nab-paclitaxel (125 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
Randomized Arm 3
gemcitabine + nab-paclitaxel
gemcitabine
SOC chemotherapy. Gemcitabine (1000 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
nab-paclitaxel
SOC chemotherapy. Nab-paclitaxel (125 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
Interventions
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NIS793
anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.
Spartalizumab
anti-PD-1 antibody. spartalizumab 400 mg every 4 weeks by i.v. infusion.
gemcitabine
SOC chemotherapy. Gemcitabine (1000 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
nab-paclitaxel
SOC chemotherapy. Nab-paclitaxel (125 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female ≥ 18 years of age at the time of informed consent.
3. Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1.
4. Participants must have a site of disease amenable to biopsy, and be candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a tumor biopsy at screening and during therapy on the study. In the event a new biopsy cannot be safely performed at study entry, an archival sample (collected \<6 months prior) may be substituted following documented discussion with Novartis.
5. ECOG performance status ≤ 1.
Exclusion Criteria
2. Participants amenable to potentially curative resection.
3. Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors.
4. Having out of range laboratory values as pre-defined in the protocol.
5. Participants with MSI-H pancreatic adenocarcinoma.
6. Presence of symptomatic CNS metastases, or CNS metastases that require local CNS directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry.
7. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
8. The participant exhibits any of the events outlined in the contra-indications or special warnings and precautions sections of gemcitabine and nab-paclitaxel as per locally approved labels.
9. Impaired cardiac function or clinically significant cardiac disease.
10. Known history of testing positive HIV infection.
11. Active HBV or HCV infection. Participants whose disease is controlled under antiviral therapy should not be excluded.
12. History of or current interstitial lung disease or pneumonitis grade ≥ 2
13. High risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Winship Cancer Institute
Atlanta, Georgia, United States
Sidney Kimmel CCC At JH
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Cente
Boston, Massachusetts, United States
Univ of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Salzburg, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Brno, Czech Republic, Czechia
Novartis Investigative Site
Helsinki, , Finland
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Verona, VR, Italy
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Sankt Gallen, , Switzerland
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2020-000349-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNIS793B12201
Identifier Type: -
Identifier Source: org_study_id
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