For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

Applicable for both Safety run-in and Randomized part

  1. 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
  2. Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. Adequate organ function (assessed by central laboratory for eligibility)
  5. 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

  1. Previous systemic anti-cancer treatment for metastatic PDAC
  2. Pancreatic neuroendocrine (islet) or acinar tumors
  3. 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).
  4. 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.
  5. 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).
  6. Impaired cardiac function or clinically significant cardio-vascular disease
  7. Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.
  8. 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.
  9. Serious non-healing wounds.
  10. Pregnant or breast-feeding women
  11. Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated
  12. Pre-existing peripheral neuropathy > grade 1 (CTCAE v5.0)

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Metastatic Pancreatic Ductal Adenocarcinoma

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Jan 1, 2026

Treatment type



Novartis identifier


Study number


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