A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (daNIS-1)

  • End date
    Oct 24, 2023
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 13 October 2022


The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in untreated mPDAC.

Condition Metastatic Pancreatic Ductal Adenocarcinoma
Treatment Gemcitabine, Nab-paclitaxel, NIS793, spartalizumab
Clinical Study IdentifierNCT04390763
SponsorNovartis Pharmaceuticals
Last Modified on13 October 2022


Yes No Not Sure

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study
Male or female ≥ 18 years of age at the time of informed consent
Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1
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
ECOG performance status ≤ 1

Exclusion Criteria

Previous radiotherapy, surgery (with exception of placement of biliary stent, which is allowed), chemotherapy or any other investigational therapy for the treatment of metastatic pancreatic cancer. Participants having received previous chemotherapy in the adjuvant setting
Participants amenable to potentially curative resection
Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors
Having out of range laboratory values as pre-defined in the protocol
Participants with MSI-H pancreatic adenocarcinoma
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
History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients
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
Impaired cardiac function or clinically significant cardiac disease
Known history of testing positive HIV infection
Active HBV or HCV infection. Participants whose disease is controlled under antiviral therapy should not be excluded
History of or current interstitial lung disease or pneumonitis grade ≥ 2
High risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding
Other protocol-defined inclusion/exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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