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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic Arizona - Phoenix Campus
  Phoenix, Arizona, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• University of California San Diego Health
  La Jolla, California, United States Recruiting
• Cancer & Blood Specialty Clinic - Los Alamitos
  Los Alamitos, California, United States Recruiting
• Keck Medicine of USC - Keck Hospital of USC
  Los Angeles, California, United States Recruiting
• UCLA Health - Santa Monica Cancer Care
  Santa Monica, California, United States Recruiting

+54 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Arcus Biosciences
• Email: ClinicalTrialInquiry@arcusbio.com
• Phone: +1-510-462-3330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.