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New hope for tough pancreatic cancer? drug combo trial shows promise

NCT ID NCT04935359

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 a new drug called NIS793 added to standard chemotherapy for people with metastatic pancreatic cancer that has spread. The goal was to see if the combination could help patients live longer by reducing scar tissue in the tumor. About 511 adults with this advanced cancer took part in the study.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

511 people

The number who actually took part.

Started

Sep 2021

Finished

Aug 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.

Key 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. Key Main Exclusion Criteria: Applicable for both Safety run-in and Randomized part * Previous systemic anti-cancer treatment for metastatic PDAC * Pancreatic neuroendocrine (islet) or acinar 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) Other Inclusion/Exclusion criteria may apply.

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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

  • AdventHealth

    Orlando, Florida, 32804, United States

  • Fort Wayne Medical Oncology Hematology Inc

    Fort Wayne, Indiana, 46815, United States

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • NYU Clinical Cancer Center

    New York, New York, 10016, United States

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Perth, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Bonheiden, 2820, Belgium

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Edegem, 2650, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Brasília, Federal District, 70200-730, Brazil

  • Novartis Investigative Site

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002, Brazil

  • Novartis Investigative Site

    Brampton, Ontario, L6R 3J7, Canada

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 3G2, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150081, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    Dalian, Liaoning, 116001, China

  • Novartis Investigative Site

    Jining, Shandong, 272000, China

  • Novartis Investigative Site

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022, China

  • Novartis Investigative Site

    Beijing, 100021, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Shanghai, 200032, China

  • Novartis Investigative Site

    Shanghai, 200127, China

  • Novartis Investigative Site

    Shanghai, 200433, China

  • Novartis Investigative Site

    Tianjin, 300480, China

  • Novartis Investigative Site

    Brno, 656 53, Czechia

  • Novartis Investigative Site

    Hradec Králové, 500 05, Czechia

  • Novartis Investigative Site

    Nový Jičín, 741 01, Czechia

  • Novartis Investigative Site

    Prague, 140 59, Czechia

  • Novartis Investigative Site

    Helsinki, 00290, Finland

  • Novartis Investigative Site

    Tampere, FIN-33521, Finland

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189, France

  • Novartis Investigative Site

    Avignon, 84082, France

  • Novartis Investigative Site

    Besançon, 25030, France

  • Novartis Investigative Site

    Créteil, 94010, France

  • Novartis Investigative Site

    Lyon 08, 69373, France

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75015, France

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60488, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Bochum, 44791, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Hamburg, 20249, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Thessaloniki, 540 07, Greece

  • Novartis Investigative Site

    Thessaloniki, 570 01, Greece

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, H 1122, Hungary

  • Novartis Investigative Site

    Budapest, H-1097, Hungary

  • Novartis Investigative Site

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4648681, Japan

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8577, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5418567, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    Koto Ku, Tokyo, 1358550, Japan

  • Novartis Investigative Site

    Utrecht, 3543 AZ, Netherlands

  • Novartis Investigative Site

    Nordbyhagen, Oslo, 1478, Norway

  • Novartis Investigative Site

    Oslo, NO-0407, Norway

  • Novartis Investigative Site

    Omsk, 644013, Russia

  • Novartis Investigative Site

    Saint Petersburg, 196603, Russia

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Banská Bystrica, 975 17, Slovakia

  • Novartis Investigative Site

    Bratislava, 83310, Slovakia

  • Novartis Investigative Site

    Košice, 041 91, Slovakia

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Malmö, SE-205 02, Sweden

  • Novartis Investigative Site

    Umeå, 901 85, Sweden

  • Novartis Investigative Site

    Bellinzona, 6500, Switzerland

  • Novartis Investigative Site

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    Sankt Gallen, 9007, Switzerland

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Istanbul, Kadikoy, 34722, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Adana, Yuregir, 01250, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    Liverpool, CH63 4JY, United Kingdom

  • Novartis Investigative Site

    London, EC1A 7BE, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • US Oncology Research Dallas

    Dallas, Texas, 75204, United States

  • University of California LA

    Los Angeles, California, 90095, United States

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