Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
PRISM-1
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
3 other identifiers
interventional
610
12 countries
107
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2024
Longer than P75 for phase_3
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedStudy Start
First participant enrolled
December 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2030
July 31, 2026
May 1, 2026
6 years
September 20, 2024
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Up to 72 months
Secondary Outcomes (5)
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Up to 72 months
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
Up to 72 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Up to 72 months
Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1
Up to 72 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Up to 72 months
Study Arms (2)
Arm A (Experimental Arm)
EXPERIMENTALQuemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
Arm B (Comparator Arm)
PLACEBO COMPARATORPlacebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- Have histologically or cytologically confirmed PDAC that is metastatic.
- Have not been previously treated for PDAC in the metastatic setting.
- Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
- 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.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arcus Biosciences, Inc.lead
- Taiho Pharmaceutical Co., Ltd.collaborator
Study Sites (111)
Research Site
Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85724, United States
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La Jolla, California, 92093, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90033-5315, United States
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Roseville, California, 95661, United States
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San Francisco, California, 94158, United States
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Santa Monica, California, 90404, United States
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Denver, Colorado, 80218, United States
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New Haven, Connecticut, 06520, United States
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Jacksonville, Florida, 32224-1865, United States
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Miami, Florida, 33176, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Arlington Heights, Illinois, 60005, United States
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Chicago, Illinois, 60611, United States
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Indianapolis, Indiana, 46202, United States
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Wichita, Kansas, 67208, United States
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Baton Rouge, Louisiana, 70809, United States
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Ann Arbor, Michigan, 48109, United States
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Grand Rapids, Michigan, 49503, United States
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Minneapolis, Minnesota, 55404, United States
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Rochester, Minnesota, 55905, United States
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Hattiesburg, Mississippi, 39401, United States
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Kansas City, Missouri, 64111, United States
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Omaha, Nebraska, 68105, United States
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New Brunswick, New Jersey, 08903-2681, United States
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Buffalo, New York, 14263, United States
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New York, New York, 10016, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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New York, New York, 10128, United States
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Rochester, New York, 14642, United States
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Cleveland, Ohio, 44106, United States
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Oklahoma City, Oklahoma, 73104, United States
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Philadelphia, Pennsylvania, 19111-2497, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78240, United States
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Webster, Texas, 77598, United States
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Fairfax, Virginia, 22031, United States
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Seattle, Washington, 98101, United States
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Spokane, Washington, 99208, United States
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Vancouver, Washington, 98684, United States
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Madison, Wisconsin, 53792, United States
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Camperdown, Australia
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Clayton, Australia
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Murdoch, Australia
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Wollongong, Australia
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Salzburg, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Anderlecht, Belgium
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Bonheiden, Belgium
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Kortrijk, Belgium
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Ottawa, Canada
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Sherbrooke, Canada
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Toronto, Canada
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Brno, Czechia
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Nový Jičín, Czechia
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Prague, Czechia
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Dijon, France
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Lille, France
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Lyon, France
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Poitiers, France
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Villejuif, France
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Bochum, Germany
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Frankfurt am Main, Germany
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Hamburg, Germany
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Hanover, Germany
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Heilbronn, Germany
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Magdeburg, Germany
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Riesa, Germany
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Ulm, Germany
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Würzburg, Germany
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Bologna, Italy
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Cremona, Italy
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Florence, Italy
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Milan, Italy
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Modena, Italy
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Padova, Italy
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Piacenza, Italy
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Roma, Italy
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Rozzano, Italy
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Torrette, Italy
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Verona, Italy
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Kashiwa-shi, Japan
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Kōtō City, Japan
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Osaka, Japan
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Tokyo, Japan
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Toyama, Japan
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Ube, Japan
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Yokohama, Japan
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Hwasun, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Elche, Spain
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Girona, Spain
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Madrid, Spain
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Pamplona, Spain
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Vigo, Spain
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Zaragoza, Spain
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Birmingham, United Kingdom
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Cottingham, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2024
First Posted
September 23, 2024
Study Start
December 13, 2024
Primary Completion (Estimated)
November 30, 2030
Study Completion (Estimated)
November 30, 2030
Last Updated
July 31, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
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.