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Comparing quemliclustat with chemotherapy to placebo with chemotherapy for metastatic pancreatic cancer

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

Phase 3 Interventional Arcus Biosciences, Inc. · NCT06608927

This study is testing if adding a new drug called quemliclustat to standard chemotherapy can help people with metastatic pancreatic cancer live longer compared to those who only receive chemotherapy with a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment610 (estimated)
Ages18 Years and up
SexAll
SponsorArcus Biosciences, Inc. Industry-sponsored
Drugs / interventionsradiation
Locations104 sites (Phoenix, Arizona and 103 other locations)
Trial IDNCT06608927 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the overall survival of patients with metastatic pancreatic ductal adenocarcinoma (PDAC) receiving quemliclustat in combination with nab-paclitaxel and gemcitabine compared to those receiving a placebo with the same chemotherapy regimen. It is a Phase 3 interventional trial that includes patients who have not been previously treated for metastatic PDAC. Participants will be randomized to receive either the investigational drug or placebo alongside standard chemotherapy. The study will measure the effectiveness of the treatment in improving survival outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma who have not received prior treatment for their metastatic disease.

Not a fit: Patients who have previously been treated for locally advanced, unresectable pancreatic cancer or have a history of brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with metastatic pancreatic cancer.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 103 other locations

+54 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Pancreatic Ductal AdenocarcinomaQuemliclustatCD73 InhibitorTreatment naivePancreatic cancerPRISM-1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.