Clinical trial NCT06608927: Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Keywords: Quemliclustat
CD73 Inhibitor
Metastatic Pancreatic Ductal Adenocarcinoma
Treatment naive
Pancreatic cancer
PRISM-1
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Taiho Pharmaceutical Co., Ltd.
First posted: 2024-09-23
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 72 months
Secondary outcomes:
measure: Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 72 months
measure: Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 72 months
measure: Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 72 months
measure: Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 72 months
measure: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 72 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona - Phoenix Campus
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego Health
state: California
city: Los Alamitos
country: United States
facility: Cancer & Blood Specialty Clinic - Los Alamitos
state: California
city: Los Angeles
country: United States
facility: Keck Medicine of USC - Keck Hospital of USC
state: California
city: Santa Monica
country: United States
facility: UCLA Health - Santa Monica Cancer Care
state: California
city: Denver
country: United States
facility: USOR - Rocky Mountain Cancer Centers - Denver - Midtown
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Arlington Heights
country: United States
facility: USOR - Illinois Cancer Specialists - Arlington Heights
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas - Medical Arts Tower
state: Kansas
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center - Baton Rouge
state: Louisiana
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
state: Michigan
city: Minneapolis
country: United States
facility: HealthPartners Cancer Research Center - Cancer Center at Regions Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Hattiesburg
country: United States
facility: MediSync Clinical Research - Hattiesburg Clinic
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New Hyde Park
country: United States
facility: Clinical Research Alliance
state: New York
city: New York
country: United States
facility: New York University Medical Oncology Associates
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center - Herbert Irving Pavilion
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center Comprehensive Cancer Center
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: USOR - Texas Oncology - Austin Midtown
state: Texas
city: Dallas
country: United States
facility: USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: USOR - Texas Oncology - San Antonio Medical Center
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Summit Cancer Centers - Spokane Valley
state: Washington
city: Vancouver
country: United States
facility: USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Clayton
country: Australia
facility: Monash Health
city: Murdoch
country: Australia
facility: Oncology West - Murdoch
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Sankt Pölten
country: Austria
facility: Universitätsklinikum Sankt Pölten
city: Wien
country: Austria
facility: Krankenhaus Der Barmherzigen Brüder Wien
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Kortrijk
country: Belgium
facility: Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre - Bayview Campus
city: Dijon cedex
country: France
facility: Centre Georges François Leclerc
city: Lille Cedex
country: France
facility: Hôpital Huriez
city: Lyon
country: France
facility: Centre Léon Bérard
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Villejuif
country: France
facility: Gustave Roussy
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Cremona
country: Italy
facility: Ospedale di Cremona
city: Milano
country: Italy
facility: Fondazione IRCCS - Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Roma
country: Italy
facility: IRCCS Istituto Nazionale Tumori Regina Elena
city: Rozzano
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
city: Torrette
country: Italy
facility: Azienda Ospedaliero Universitaria Delle Marche
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Ube
country: Japan
facility: Yamaguchi University Hospital
city: Yokohama-Shi
country: Japan
facility: Kanagawa Cancer Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam
country: Korea, Republic of
facility: Cha Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
city: Cottingham
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute London
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: