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

May 29, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
610

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 72 months
Up to 72 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcus Biosciences, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taiho Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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