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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    501
  • sponsor
    Novartis Pharmaceuticals
Updated on 14 May 2022

Summary

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.

Description

This is a randomized, double-blind, multicenter two-arm, phase III study that has two parts:

  • 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.

Details
Condition Metastatic Pancreatic Ductal Adenocarcinoma
Treatment Placebo, Gemcitabine, Nab-paclitaxel, NIS793
Clinical Study IdentifierNCT04935359
SponsorNovartis Pharmaceuticals
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

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

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)
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