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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

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 adverse events (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 or psychiatric 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
Oncology West - Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Austria
State/province [14] 0 0
Sankt Pölten
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Japan
State/province [18] 0 0
Kashiwa-shi
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Japan
State/province [20] 0 0
Ube
Country [21] 0 0
Japan
State/province [21] 0 0
Yokohama-Shi
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seongnam
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid

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


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