Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Last updated: April 8, 2025
Sponsor: Arcus Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Adenocarcinoma

Treatment

Nab-paclitaxel

Gemcitabine

Quemliclustat

Clinical Study ID

NCT06608927
PRISM-1
jRCT2061240084
2024-513317-12-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have histologically or cytologically confirmed PDAC that is metastatic.

  • Have not been previously treated for PDAC in the metastatic setting.

  1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed atleast 12 months before randomization.

  2. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior torandomization and AEs have resolved to Grade 1 or less before randomization.

  3. Prior and/or placement of a biliary stent/tube is permitted if anytreatment-related AEs have improved to Grade ≤ 1 and the patient is notexhibiting any signs/symptoms of biliary obstruction.

  • Eastern Cooperative Oncology Group PS of 0 to 1.

  • At least 1 target lesion measurable by computed tomography (CT)/magnetic resonanceimaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.

Exclusion

Exclusion Criteria:

  • Previously treated for locally advanced, unresectable PDAC.

  • History of brain metastases or leptomeningeal metastases.

  • Prior treatment with a CD73 antagonist or inhibitor.

  • Underlying medical conditions that, in the investigator or sponsor's opinion, willmake the administration of study-specified therapy hazardous

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 610
Treatment Group(s): 4
Primary Treatment: Nab-paclitaxel
Phase: 3
Study Start date:
December 13, 2024
Estimated Completion Date:
November 30, 2030

Connect with a study center

  • Oncology West - Murdoch

    Murdoch,
    Australia

    Active - Recruiting

  • Wollongong Hospital

    Wollongong,
    Australia

    Active - Recruiting

  • Universitätsklinikum Sankt Pölten

    Sankt Pölten,
    Austria

    Active - Recruiting

  • Krankenhaus Der Barmherzigen Brüder Wien

    Wien,
    Austria

    Active - Recruiting

  • Imeldaziekenhuis

    Bonheiden,
    Belgium

    Active - Recruiting

  • Gustave Roussy

    Villejuif,
    France

    Active - Recruiting

  • Krankenhaus Nordwest

    Frankfurt am Main,
    Germany

    Active - Recruiting

  • Ospedale di Cremona

    Cremona,
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milano,
    Italy

    Active - Recruiting

  • Ospedale Guglielmo da Saliceto

    Piacenza,
    Italy

    Active - Recruiting

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

    Rozzano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Delle Marche

    Torrette,
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi,
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Toyama University Hospital

    Toyama,
    Japan

    Active - Recruiting

  • Yamaguchi University Hospital

    Ube,
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama-Shi,
    Japan

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun,
    Korea, Republic of

    Active - Recruiting

  • Cha Bundang Medical Center

    Seongnam,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona,
    Spain

    Active - Recruiting

  • Clínica Universidad de Navarra - Madrid

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona,
    Spain

    Active - Recruiting

  • Sarah Cannon Research Institute London

    London,
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Oxford,
    United Kingdom

    Active - Recruiting

  • Mayo Clinic Arizona - Phoenix Campus

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Cancer & Blood Specialty Clinic - Los Alamitos

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Keck Medicine of USC - Keck Hospital of USC

    Los Angeles, California 90033-5315
    United States

    Active - Recruiting

  • UCLA Health - Santa Monica Cancer Care

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224-1865
    United States

    Active - Recruiting

  • Miami Cancer Institute

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Piedmont Atlanta Hospital

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • HealthPartners Cancer Research Center - Cancer Center at Regions Hospital

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • MediSync Clinical Research - Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903-2681
    United States

    Active - Recruiting

  • Clinical Research Alliance

    New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center - Herbert Irving Pavilion

    New York, New York 10032
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111-2497
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • Summit Cancer Centers - Spokane Valley

    Spokane, Washington 99208
    United States

    Active - Recruiting

  • University of Wisconsin - Madison

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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