Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PRISM-1)

May 6, 2026 updated by: Arcus Biosciences, Inc.

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

610

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia
        • Research Site
      • Clayton, Australia
        • Research Site
      • Murdoch, Australia
        • Research Site
      • Wollongong, Australia
        • Research Site
  • Austria
      • Salzburg, Austria
        • Research Site
      • Sankt Pölten, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
  • Belgium
      • Anderlecht, Belgium
        • Research Site
      • Bonheiden, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
  • Canada
      • Ottawa, Canada
        • Research Site
      • Sherbrooke, Canada
        • Research Site
      • Toronto, Canada
        • Research Site
  • Czechia
      • Brno, Czechia
        • Research Site
      • Nový Jičín, Czechia
        • Research Site
      • Prague, Czechia
        • Research Site
  • France
      • Dijon, France
        • Research Site
      • Lille, France
        • Research Site
      • Lyon, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Villejuif, France
        • Research Site
  • Germany
      • Bochum, Germany
        • Research Site
      • Frankfurt am Main, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hanover, Germany
        • Research Site
      • Heilbronn, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Riesa, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
      • Würzburg, Germany
        • Research Site
  • Italy
      • Bologna, Italy
        • Research Site
      • Cremona, Italy
        • Research Site
      • Florence, Italy
        • Research Site
      • Milan, Italy
        • Research Site
      • Modena, Italy
        • Research Site
      • Padova, Italy
        • Research Site
      • Piacenza, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Rozzano, Italy
        • Research Site
      • Torrette, Italy
        • Research Site
      • Verona, Italy
        • Research Site
  • Japan
      • Kashiwa-shi, Japan
        • Research Site
      • Kōtō City, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Toyama, Japan
        • Research Site
      • Ube, Japan
        • Research Site
      • Yokohama, Japan
        • Research Site
  • South Korea
      • Hwasun, South Korea
        • Research Site
      • Seongnam, South Korea
        • Research Site
      • Seoul, South Korea
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Elche, Spain
        • Research Site
      • Girona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Pamplona, Spain
        • Research Site
      • Vigo, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Cottingham, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
      • Tucson, Arizona, United States, 85724
        • Research Site
    • California
      • La Jolla, California, United States, 92093
        • Research Site
      • Los Alamitos, California, United States, 90720
        • Research Site
      • Los Angeles, California, United States, 90033-5315
        • Research Site
      • Roseville, California, United States, 95661
        • Research Site
      • San Francisco, California, United States, 94158
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224-1865
        • Research Site
      • Miami, Florida, United States, 33176
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Research Site
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Research Site
      • Chicago, Illinois, United States, 60611
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Grand Rapids, Michigan, United States, 49503
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903-2681
        • Research Site
    • New York
      • Buffalo, New York, United States, 14263
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
      • New York, New York, United States, 10065
        • Research Site
      • New York, New York, United States, 10128
        • Research Site
      • Rochester, New York, United States, 14642
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Texas
      • Austin, Texas, United States, 78705
        • Research Site
      • Dallas, Texas, United States, 75246
        • Research Site
      • Dallas, Texas, United States, 75390
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78240
        • Research Site
      • Webster, Texas, United States, 77598
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Research Site
      • Spokane, Washington, United States, 99208
        • Research Site
      • Vancouver, Washington, United States, 98684
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 at least 12 months before randomization.
    2. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and AEs have resolved to Grade 1 or less before randomization.
    3. Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade ≤ 1 and the patient is not exhibiting 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 resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.

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, will make the administration of study-specified therapy hazardous

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Experimental Arm)
Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
Drug: Quemliclustat
Administered as specified in the treatment arm
Drug: Nab-paclitaxel
Administered as specified in the treatment arm
Drug: Gemcitabine
Administered as specified in the treatment arm
Placebo Comparator: Arm B (Comparator Arm)
Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
Drug: Placebo
Administered as specified in the treatment arm
Drug: Nab-paclitaxel
Administered as specified in the treatment arm
Drug: Gemcitabine
Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 72 months
Up to 72 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Time Frame: Up to 72 months
Up to 72 months
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
Time Frame: Up to 72 months
Up to 72 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Time Frame: Up to 72 months
Up to 72 months
Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1
Time Frame: Up to 72 months
Up to 72 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 72 months
Up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcus Biosciences, Inc.

Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Medical Director, Arcus Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

November 30, 2030

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRISM-1
  • 2024-513317-12-00 (Ctis)
  • jRCT2061240084 (Other Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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