ClinicalTrials.gg
Active, not recruitingNCT06608927PRISM-1Updated Nov 2, 2026

Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 3 interventional study of Quemliclustat and Placebo in Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by Arcus Biosciences, Inc.. Active, not recruiting at 111 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Arcus Biosciences, Inc. · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
610
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,852 studies in Pancreatic Neoplasms with a site in United States — 302 open to participants now, 474 under way, 25 of them phase 3. Pancreatic Neoplasms · United States.

Planned enrollment
39th of 1,575
610 · median 37
Started
2024
with 67 others
Phase 3
80 of 1,852
14 open now
Primary completion
2030-11
later than 437 of 473 live
Registered
1,694th of 1,852
by date

Among the 1,852 studies in Pancreatic Neoplasms with a site in United States, this one is the 39th largest by planned enrollment of the 1,575 interventional ones that give a count, is one of 68 that started in 2024, is one of 80 in phase 3, reaches primary completion later than 437 of the 473 other live ones, and was the 1,694th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

302 of the 1,852 studies in Pancreatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:

297 more — sign in →

All 302 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

  • Quemliclustat
  • CD73 Inhibitor
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Treatment naive
  • Pancreatic cancer
  • PRISM-1
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have or cytologically confirmed PDAC that is .
  • Have not been previously treated for PDAC in the metastatic setting.

    1. Prior 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.
  • PS of 0 to 1.
  • At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per v1.1. not within a field of prior radiation therapy.

Exclusion criteria

Exclusion Criteria:

  • Previously treated for locally advanced, unresectable PDAC.
  • History of or .
  • 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.

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
610 participants (estimated)

Study arms

  • Experimental
    Arm A (Experimental Arm)

    Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion

    Drug: Quemliclustat · Drug: Nab-paclitaxel · Drug: Gemcitabine

  • Placebo comparator
    Arm B (Comparator Arm)

    Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion

    Drug: Placebo · Drug: Nab-paclitaxel · Drug: Gemcitabine

Interventions

  • Administered as specified in the treatment arm

  • DrugPlacebo

    Administered as specified in the treatment arm

  • Administered as specified in the treatment arm

  • Administered as specified in the treatment arm

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 72 months

Secondary outcomes

  1. Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  2. Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  3. Duration of response (DoR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  4. Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  5. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 72 months

07

Study locations

111 sites
  • Research Site
    Phoenix, Arizona 85054, United States
  • Research Site
    Tucson, Arizona 85724, United States
  • Research Site
    La Jolla, California 92093, United States
  • Research Site
    Los Alamitos, California 90720, United States
  • Research Site
    Los Angeles, California 90033-5315, United States
  • Research Site
    Roseville, California 95661, United States
  • Research Site
    San Francisco, California 94158, United States
  • Research Site
    Santa Monica, California 90404, United States
  • Research Site
    Denver, Colorado 80218, United States
  • Research Site
    New Haven, Connecticut 06520, United States
  • Research Site
    Jacksonville, Florida 32224-1865, United States
  • Research Site
    Miami, Florida 33176, United States
  • Research Site
    Atlanta, Georgia 30318, United States
  • Research Site
    Atlanta, Georgia 30322, United States
  • Research Site
    Arlington Heights, Illinois 60005, United States
  • Research Site
    Chicago, Illinois 60611, United States
  • Research Site
    Indianapolis, Indiana 46202, United States
  • Research Site
    Wichita, Kansas 67208, United States
  • Research Site
    Baton Rouge, Louisiana 70809, United States
  • Research Site
    Ann Arbor, Michigan 48109, United States
  • Research Site
    Grand Rapids, Michigan 49503, United States
  • Research Site
    Minneapolis, Minnesota 55404, United States
  • Research Site
    Rochester, Minnesota 55905, United States
  • Research Site
    Hattiesburg, Mississippi 39401, United States
  • Research Site
    Kansas City, Missouri 64111, United States
  • Research Site
    Omaha, Nebraska 68105, United States
  • Research Site
    New Brunswick, New Jersey 08903-2681, United States
  • Research Site
    Buffalo, New York 14263, United States
  • Research Site
    New York, New York 10016, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    New York, New York 10065, United States
  • Research Site
    New York, New York 10128, United States
  • Research Site
    Rochester, New York 14642, United States
  • Research Site
    Cleveland, Ohio 44106, United States
  • Research Site
    Oklahoma City, Oklahoma 73104, United States
  • Research Site
    Philadelphia, Pennsylvania 19111-2497, United States
  • Research Site
    Pittsburgh, Pennsylvania 15232, United States
  • Research Site
    Nashville, Tennessee 37232, United States
  • Research Site
    Austin, Texas 78705, United States
  • Research Site
    Dallas, Texas 75246, United States
  • Research Site
    Dallas, Texas 75390, United States
  • Research Site
    Houston, Texas 77030, United States
  • Research Site
    San Antonio, Texas 78240, United States
  • Research Site
    Webster, Texas 77598, United States
  • Research Site
    Fairfax, Virginia 22031, United States
  • Research Site
    Seattle, Washington 98101, United States
  • Research Site
    Spokane, Washington 99208, United States
  • Research Site
    Vancouver, Washington 98684, United States
  • Research Site
    Madison, Wisconsin 53792, United States
  • Research Site
    Camperdown, Australia
  • Research Site
    Clayton, Australia
  • Research Site
    Murdoch, Australia
  • Research Site
    Wollongong, Australia
  • Research Site
    Salzburg, Austria
  • Research Site
    Sankt Pölten, Austria
  • Research Site
    Vienna, Austria
  • Research Site
    Anderlecht, Belgium
  • Research Site
    Bonheiden, Belgium
  • Research Site
    Kortrijk, Belgium
  • Research Site
    Ottawa, Canada
  • Research Site
    Sherbrooke, Canada
  • Research Site
    Toronto, Canada
  • Research Site
    Brno, Czechia
  • Research Site
    Nový Jičín, Czechia
  • Research Site
    Prague, Czechia
  • Research Site
    Dijon, France
  • Research Site
    Lille, France
  • Research Site
    Lyon, France
  • Research Site
    Poitiers, France
  • Research Site
    Villejuif, France
  • Research Site
    Bochum, Germany
  • Research Site
    Frankfurt am Main, Germany
  • Research Site
    Hamburg, Germany
  • Research Site
    Hanover, Germany
  • Research Site
    Heilbronn, Germany
  • Research Site
    Magdeburg, Germany
  • Research Site
    Riesa, Germany
  • Research Site
    Ulm, Germany
  • Research Site
    Würzburg, Germany
  • Research Site
    Bologna, Italy
  • Research Site
    Cremona, Italy
  • Research Site
    Florence, Italy
  • Research Site
    Milan, Italy
  • Research Site
    Modena, Italy
  • Research Site
    Padova, Italy
  • Research Site
    Piacenza, Italy
  • Research Site
    Roma, Italy
  • Research Site
    Rozzano, Italy
  • Research Site
    Torrette, Italy
  • Research Site
    Verona, Italy
  • Research Site
    Kashiwa-shi, Japan
  • Research Site
    Kōtō City, Japan
  • Research Site
    Osaka, Japan
  • Research Site
    Tokyo, Japan
  • Research Site
    Toyama, Japan
  • Research Site
    Ube, Japan
  • Research Site
    Yokohama, Japan
  • Research Site
    Hwasun, South Korea
  • Research Site
    Seongnam, South Korea
  • Research Site
    Seoul, South Korea

Showing the first 100 of 111 sites across 13 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Data sharing details ↗ · trials.arcusbio.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Nov 2030, 71 months after the start.

Of 84 phase 3 interventional studies under Pancreatic Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 77. This study's planned 71 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2024
First posted
Sep 23, 2024
StartActual
Dec 13, 2024
Primary completionEst.
Nov 30, 2030
CompletionEst.
Nov 30, 2030
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: site details
1 update, last Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Minor edits only
    + 1 other change: site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06608927
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Dec 13, 2024
Primary completion
Nov 30, 2030 (estimated)
Completion
Nov 30, 2030 (estimated)
Last update
Nov 2, 2026

Study contacts

Medical Director
study director · Arcus Biosciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Quemliclustat

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