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
121
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
121 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
April 1, 2026
April 1, 2025
6 years
September 20, 2024
March 30, 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 (125)
Mayo Clinic Arizona - Phoenix Campus
Phoenix, Arizona, 85054, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of California San Diego Health
La Jolla, California, 92093, United States
Cancer & Blood Specialty Clinic - Los Alamitos
Los Alamitos, California, 90720, United States
Keck Medicine of USC - Keck Hospital of USC
Los Angeles, California, 90033-5315, United States
Sutter Medical Center
Roseville, California, 95661, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, 90404, United States
USOR - Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, 80218, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224-1865, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
USOR - Illinois Cancer Specialists - Arlington Heights
Arlington Heights, Illinois, 60005, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Cancer Center of Kansas - Medical Arts Tower
Wichita, Kansas, 67208, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, 49503, United States
HealthPartners Cancer Research Center - Cancer Center at Regions Hospital
Minneapolis, Minnesota, 55404, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
MediSync Clinical Research - Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903-2681, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
New York University Medical Oncology Associates
New York, New York, 10016, United States
Columbia University Irving Medical Center - Herbert Irving Pavilion
New York, New York, 10032, United States
Memorial Sloan-Kettering Cancer Center - New York - Rockefeller Outpatient Pavilion
New York, New York, 10065, United States
Mount Sinai Medical Center Comprehensive Cancer Center
New York, New York, 10128, United States
James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
USOR - Texas Oncology - Austin Midtown
Austin, Texas, 78705, United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
USOR - Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240, United States
USOR - Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Inova Medical Group - Hematology Oncology - Arlington
Fairfax, Virginia, 22031, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Summit Cancer Centers - Spokane Valley
Spokane, Washington, 99208, United States
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
Vancouver, Washington, 98684, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792, United States
Chris O'Brien Lifehouse
Camperdown, Australia
Monash Health
Clayton, Australia
Oncology West - Murdoch
Murdoch, Australia
Wollongong Hospital
Wollongong, Australia
Salzburg Cancer Research Institute
Salzburg, Austria
Universitätsklinikum Sankt Pölten
Sankt Pölten, Austria
Krankenhaus Der Barmherzigen Brüder Wien
Vienna, Austria
Medizinische Universität Wien
Vienna, Austria
Institut Jules Bordet
Anderlecht, Belgium
Imeldaziekenhuis
Bonheiden, Belgium
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, Belgium
Ottawa Hospital - General Campus
Ottawa, Canada
Hôtel-Dieu de Sherbrooke
Sherbrooke, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto, Canada
Fakultni Nemocnice Brno
Brno, Czechia
Nemocnice AGEL Nový Jičín a.s.
Nový Jičín, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Centre Georges François Leclerc
Dijon, France
Hôpital Huriez
Lille, France
Centre Léon Bérard
Lyon, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Gustave Roussy
Villejuif, France
Katholisches Klinikum Bochum - St. Josef-Hospital
Bochum, Germany
Krankenhaus Nordwest
Frankfurt am Main, Germany
Facharztzentrum Eppendorf
Hamburg, Germany
Katholisches Marienkrankenhaus
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen
Heilbronn, Germany
Otto-von-Guericke Universität
Magdeburg, Germany
Elblandklinikum Riesa
Riesa, Germany
Universitätsklinikum Ulm
Ulm, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, Italy
Ospedale di Cremona
Cremona, Italy
Azienda Ospedaliero - Universitaria Careggi
Florence, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
Azienda Ospedaliero - Universitaria di Modena
Modena, Italy
Istituto Oncologico Veneto - IRCCS
Padua, Italy
Ospedale Guglielmo da Saliceto
Piacenza, Italy
IRCCS Istituto Nazionale Tumori Regina Elena
Roma, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
Rozzano, Italy
Azienda Ospedaliero Universitaria Delle Marche
Torrette, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
National Cancer Center Hospital East
Kashiwa-shi, Japan
Cancer Institute Hospital of JFCR
Kōtō City, Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, Japan
National Cancer Center Hospital
Tokyo, Japan
Toyama University Hospital
Toyama, Japan
Yamaguchi University Hospital
Ube, Japan
Kanagawa Cancer Center
Yokohama, Japan
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Cha Bundang Medical Center
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
Hospital General Universitario de Elche
Elche, Spain
Institut Català d'Oncologia Girona (ICO Girona)
Girona, Spain
Clínica Universidad de Navarra - Madrid
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
Vigo, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
Sarah Cannon Research Institute London
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
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
April 1, 2026
Record last verified: 2025-04
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.