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Promising pancreatic cancer combo trial halted early

NCT ID NCT04390763

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the experimental drugs NIS793 (with or without spartalizumab) to standard chemotherapy could help people with metastatic pancreatic cancer that had not been treated before. The trial enrolled 164 adults and aimed to see if the combinations slowed cancer growth better than chemo alone. However, the study was terminated early, so final results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

164 people

The number who actually took part.

Started

Oct 2020

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 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: 1. 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. 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.

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Conditions

The condition(s) this trial relates to.

pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Cente

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    Westmead, New South Wales, 2145, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    Salzburg, 5020, Austria

  • Novartis Investigative Site

    Vienna, A-1090, Austria

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Brno, Czech Republic, 656 53, Czechia

  • Novartis Investigative Site

    Helsinki, FIN-00029, Finland

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28050, Spain

  • Novartis Investigative Site

    Sankt Gallen, 9007, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • Sidney Kimmel CCC At JH

    Baltimore, Maryland, 21231, United States

  • Univ of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

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