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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06608927




Registration number
NCT06608927
Ethics application status
Date submitted
20/09/2024
Date registered
23/09/2024
Date last updated
26/06/2025

Titles & IDs
Public title
Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scientific 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
Secondary ID [1] 0 0
2024-513317-12-00
Secondary ID [2] 0 0
PRISM-1
Universal Trial Number (UTN)
Trial acronym
PRISM-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Pancreatic Ductal Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Quemliclustat
Treatment: Drugs - Placebo
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine

Experimental: Arm A (Experimental Arm) - Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion

Placebo comparator: Arm B (Comparator Arm) - Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion


Treatment: Drugs: Quemliclustat
Administered as specified in the treatment arm

Treatment: Drugs: Placebo
Administered as specified in the treatment arm

Treatment: Drugs: Nab-paclitaxel
Administered as specified in the treatment arm

Treatment: Drugs: Gemcitabine
Administered as specified in the treatment arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 72 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Timepoint [1] 0 0
Up to 72 months
Secondary outcome [2] 0 0
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
Timepoint [2] 0 0
Up to 72 months
Secondary outcome [3] 0 0
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Timepoint [3] 0 0
Up to 72 months
Secondary outcome [4] 0 0
Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1
Timepoint [4] 0 0
Up to 72 months
Secondary outcome [5] 0 0
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [5] 0 0
Up to 72 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2030
Actual
Sample size
Target
610
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Oncology West - Murdoch - Murdoch
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Murdoch
Recruitment postcode(s) [4] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Louisiana
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Jersey
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New York
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Washington
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Wisconsin
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Austria
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Salzburg
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Austria
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Sankt Pölten
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Austria
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Wien
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Belgium
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Anderlecht
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Belgium
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Bonheiden
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Belgium
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Kortrijk
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Canada
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Ottawa
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Canada
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Toronto
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France
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Dijon cedex
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France
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Lille Cedex
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France
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Lyon
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France
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Villejuif
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heilbronn
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Germany
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Ulm
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Italy
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Cremona
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Italy
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Firenze
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Italy
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Milano
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Italy
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Padova
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Italy
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Piacenza
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Verona
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Japan
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Kashiwa-shi
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Japan
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Koto
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Ube
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Japan
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Yokohama-Shi
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Spain
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Barcelona
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Spain
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Elche
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Vigo
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United Kingdom
State/province [65] 0 0
Cottingham
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
State/province [68] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arcus Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Taiho Pharmaceutical Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Arcus Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arcus Biosciences
Address 0 0
Country 0 0
Phone 0 0
+1-510-462-3330
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://trials.arcusbio.com/our-transparency-policy/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06608927