Metastatic Pancreatic Ductal AdenocarcinomaPhase 3PRISM-1NCT06608927
Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 3 study testing Quemliclustat, Nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Arcus Biosciences, Inc. at 111 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Quemliclustat, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 610 participants
- Where
- 111 sitesin 13 countries
- Study dates
- 13 Dec 2024to 30 Nov 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
111 sites in 13 countries.
111 sites in 13 countries
United States49 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Arlington Heights, Illinois, 60005
Research Site
Atlanta, Georgia, 30318
Research Site
Atlanta, Georgia, 30322
Research Site
Austin, Texas, 78705
Research Site
Baton Rouge, Louisiana, 70809
Research Site
Buffalo, New York, 14263
Research Site
Chicago, Illinois, 60611
Research Site
Cleveland, Ohio, 44106
Research Site
Dallas, Texas, 75246
Research Site
Dallas, Texas, 75390
Research Site
Denver, Colorado, 80218
Research Site
Fairfax, Virginia, 22031
Research Site
Grand Rapids, Michigan, 49503
Research Site
Hattiesburg, Mississippi, 39401
Research Site
Houston, Texas, 77030
Research Site
Indianapolis, Indiana, 46202
Research Site
Jacksonville, Florida, 32224-1865
Research Site
Kansas City, Missouri, 64111
Research Site
La Jolla, California, 92093
Research Site
Los Alamitos, California, 90720
Research Site
Los Angeles, California, 90033-5315
Research Site
Madison, Wisconsin, 53792
Research Site
Miami, Florida, 33176
Research Site
Minneapolis, Minnesota, 55404
Research Site
Nashville, Tennessee, 37232
Research Site
New Brunswick, New Jersey, 08903-2681
Research Site
New Haven, Connecticut, 06520
Research Site
New York, New York, 10016
Research Site
New York, New York, 10032
Research Site
New York, New York, 10065
Research Site
New York, New York, 10128
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Omaha, Nebraska, 68105
Research Site
Philadelphia, Pennsylvania, 19111-2497
Research Site
Phoenix, Arizona, 85054
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
Rochester, Minnesota, 55905
Research Site
Rochester, New York, 14642
Research Site
Roseville, California, 95661
Research Site
San Antonio, Texas, 78240
Research Site
San Francisco, California, 94158
Research Site
Santa Monica, California, 90404
Research Site
Seattle, Washington, 98101
Research Site
Spokane, Washington, 99208
Research Site
Tucson, Arizona, 85724
Research Site
Vancouver, Washington, 98684
Research Site
Webster, Texas, 77598
Research Site
Wichita, Kansas, 67208
Italy11 sites
Research Site
Bologna
Research Site
Cremona
Research Site
Florence
Research Site
Milan
Research Site
Modena
Research Site
Padova
Research Site
Piacenza
Research Site
Roma
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Rozzano
Research Site
Torrette
Research Site
Verona
Germany9 sites
Research Site
Bochum
Research Site
Frankfurt am Main
Research Site
Hamburg
Research Site
Hanover
Research Site
Heilbronn
Research Site
Magdeburg
Research Site
Riesa
Research Site
Ulm
Research Site
Würzburg
Japan7 sites
Research Site
Kashiwa-shi
Research Site
Kōtō City
Research Site
Osaka
Research Site
Tokyo
Research Site
Toyama
Research Site
Ube
Research Site
Yokohama
Spain7 sites
Research Site
Barcelona
Research Site
Elche
Research Site
Girona
Research Site
Madrid
Research Site
Pamplona
Research Site
Vigo
Research Site
Zaragoza
France5 sites
Research Site
Dijon
Research Site
Lille
Research Site
Lyon
Research Site
Poitiers
Research Site
Villejuif
Australia4 sites
Research Site
Camperdown
Research Site
Clayton
Research Site
Murdoch
Research Site
Wollongong
United Kingdom4 sites
Research Site
Birmingham
Research Site
Cottingham
Research Site
London
Research Site
Manchester
Austria3 sites
Research Site
Salzburg
Research Site
Sankt Pölten
Research Site
Vienna
Belgium3 sites
Research Site
Anderlecht
Research Site
Bonheiden
Research Site
Kortrijk
Canada3 sites
Research Site
Ottawa
Research Site
Sherbrooke
Research Site
Toronto
South Korea3 sites
Research Site
Hwasun
Research Site
Seongnam
Research Site
Seoul
About this study
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
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.
- Being tested
- Quemliclustat, Placebo, Nab-paclitaxel, Gemcitabine
- Keywords
- Quemliclustat, CD73 Inhibitor, Metastatic Pancreatic Ductal Adenocarcinoma, Treatment naive, Pancreatic cancer, PRISM-1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuemliclustatDrug
Administered as specified in the treatment arm
PlaceboDrug
Administered as specified in the treatment arm
Nab-paclitaxelDrug
Administered as specified in the treatment arm
GemcitabineDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Experimental Arm) | Experimental | Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion Receives: Drug: Quemliclustat; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Arm B (Comparator Arm) | Placebo comparator | Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion Receives: Drug: Placebo; Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 72 months
Secondary outcomes (5)
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Measured: Up to 72 months
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
Measured: Up to 72 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Measured: Up to 72 months
Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1
Measured: Up to 72 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start13 Dec 2024
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608927
- Sponsor's protocol ID
- PRISM-1
- Other IDs
- 2024-513317-12-00, jRCT2061240084
- Acronym
- PRISM-1
- Status last verified
- May 2026
- First submitted
- 20 Sep 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06608927
- Acronym / sponsor ID
- PRISM-1 / PRISM-1
- Keywords
- Quemliclustat, CD73 Inhibitor, Metastatic Pancreatic Ductal Adenocarcinoma, Treatment naive, Pancreatic cancer, PRISM-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Experimental Arm) | Experimental | Drug: Quemliclustat, Drug: Nab-paclitaxel, Drug: GemcitabineQuemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion |
| Arm B (Comparator Arm) | Placebo comparator | Drug: Placebo, Drug: Nab-paclitaxel, Drug: GemcitabinePlacebo, nab-paclitaxel and gemcitabine will be administered by IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have histologically or cytologically confirmed PDAC that is metastatic.
- Have not been previously treated for PDAC in the metastatic setting.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuemliclustatAdministered as specified in the treatment arm | Drug | Arm A (Experimental Arm) |
| PlaceboAdministered as specified in the treatment arm | Drug | Arm B (Comparator Arm) |
| Nab-paclitaxelAdministered as specified in the treatment arm | Drug | Arm A (Experimental Arm), Arm B (Comparator Arm) |
| GemcitabineAdministered as specified in the treatment arm | Drug | Arm A (Experimental Arm), Arm B (Comparator Arm) |
Primary outcome
Overall Survival (OS)
Time frame: Up to 72 months
5 secondary outcomes
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- PRISM-1 - Public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Arcus Biosciences
111 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quemliclustat, Nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Arcus Biosciences, Inc. at 111 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, Italy, Germany, Japan, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.