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Active, not recruitingNCT06608927PRISM-1Updated Sep 29, 2026

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

A Phase 3 interventional study of Quemliclustat and Placebo in Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by Arcus Biosciences, Inc.. Active, not recruiting at 111 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Arcus Biosciences, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
610
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

  • Quemliclustat
  • CD73 Inhibitor
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Treatment naive
  • Pancreatic cancer
  • PRISM-1
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
610 participants (estimated)

Study arms

  • Experimental
    Arm A (Experimental Arm)

    Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion

    Drug: Quemliclustat · Drug: Nab-paclitaxel · Drug: Gemcitabine

  • Placebo comparator
    Arm B (Comparator Arm)

    Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion

    Drug: Placebo · Drug: Nab-paclitaxel · Drug: Gemcitabine

Interventions

  • DrugQuemliclustat

    Administered as specified in the treatment arm

  • DrugPlacebo

    Administered as specified in the treatment arm

  • DrugNab-paclitaxel

    Administered as specified in the treatment arm

  • DrugGemcitabine

    Administered as specified in the treatment arm

05

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 72 months

Secondary outcomes

  1. Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  2. Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  3. Duration of response (DoR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  4. Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  5. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 72 months

06

Study locations

111 sites
  • Research Site
    Phoenix, Arizona 85054, United States
  • Research Site
    Tucson, Arizona 85724, United States
  • Research Site
    La Jolla, California 92093, United States
  • Research Site
    Los Alamitos, California 90720, United States
  • Research Site
    Los Angeles, California 90033-5315, United States
  • Research Site
    Roseville, California 95661, United States
  • Research Site
    San Francisco, California 94158, United States
  • Research Site
    Santa Monica, California 90404, United States
  • Research Site
    Denver, Colorado 80218, United States
  • Research Site
    New Haven, Connecticut 06520, United States
  • Research Site
    Jacksonville, Florida 32224-1865, United States
  • Research Site
    Miami, Florida 33176, United States
  • Research Site
    Atlanta, Georgia 30318, United States
  • Research Site
    Atlanta, Georgia 30322, United States
  • Research Site
    Arlington Heights, Illinois 60005, United States
  • Research Site
    Chicago, Illinois 60611, United States
  • Research Site
    Indianapolis, Indiana 46202, United States
  • Research Site
    Wichita, Kansas 67208, United States
  • Research Site
    Baton Rouge, Louisiana 70809, United States
  • Research Site
    Ann Arbor, Michigan 48109, United States
  • Research Site
    Grand Rapids, Michigan 49503, United States
  • Research Site
    Minneapolis, Minnesota 55404, United States
  • Research Site
    Rochester, Minnesota 55905, United States
  • Research Site
    Hattiesburg, Mississippi 39401, United States
  • Research Site
    Kansas City, Missouri 64111, United States
  • Research Site
    Omaha, Nebraska 68105, United States
  • Research Site
    New Brunswick, New Jersey 08903-2681, United States
  • Research Site
    Buffalo, New York 14263, United States
  • Research Site
    New York, New York 10016, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    New York, New York 10065, United States
  • Research Site
    New York, New York 10128, United States
  • Research Site
    Rochester, New York 14642, United States
  • Research Site
    Cleveland, Ohio 44106, United States
  • Research Site
    Oklahoma City, Oklahoma 73104, United States
  • Research Site
    Philadelphia, Pennsylvania 19111-2497, United States
  • Research Site
    Pittsburgh, Pennsylvania 15232, United States
  • Research Site
    Nashville, Tennessee 37232, United States
  • Research Site
    Austin, Texas 78705, United States
  • Research Site
    Dallas, Texas 75246, United States
  • Research Site
    Dallas, Texas 75390, United States
  • Research Site
    Houston, Texas 77030, United States
  • Research Site
    San Antonio, Texas 78240, United States
  • Research Site
    Webster, Texas 77598, United States
  • Research Site
    Fairfax, Virginia 22031, United States
  • Research Site
    Seattle, Washington 98101, United States
  • Research Site
    Spokane, Washington 99208, United States
  • Research Site
    Vancouver, Washington 98684, United States
  • Research Site
    Madison, Wisconsin 53792, United States
  • Research Site
    Camperdown, Australia
  • Research Site
    Clayton, Australia
  • Research Site
    Murdoch, Australia
  • Research Site
    Wollongong, Australia
  • Research Site
    Salzburg, Austria
  • Research Site
    Sankt Pölten, Austria
  • Research Site
    Vienna, Austria
  • Research Site
    Anderlecht, Belgium
  • Research Site
    Bonheiden, Belgium
  • Research Site
    Kortrijk, Belgium
  • Research Site
    Ottawa, Canada
  • Research Site
    Sherbrooke, Canada
  • Research Site
    Toronto, Canada
  • Research Site
    Brno, Czechia
  • Research Site
    Nový Jičín, Czechia
  • Research Site
    Prague, Czechia
  • Research Site
    Dijon, France
  • Research Site
    Lille, France
  • Research Site
    Lyon, France
  • Research Site
    Poitiers, France
  • Research Site
    Villejuif, France
  • Research Site
    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
    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
    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
    Hwasun, South Korea
  • Research Site
    Seongnam, South Korea
  • Research Site
    Seoul, South Korea

Showing the first 100 of 111 sites across 13 countries.

07

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

08

Registry details

Key details

Study ID
NCT06608927
Lead sponsor
Arcus Biosciences, Inc.
Collaborators
Taiho Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Dec 13, 2024
Primary completion
Nov 30, 2030 (estimated)
Completion
Nov 30, 2030 (estimated)
Last update
Sep 29, 2026

Study contacts

Medical Director
study director · Arcus Biosciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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