Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around
Principal Investigator
by Zev A. Wainberg, MD
Headshot of Zev A. Wainberg
Zev A. Wainberg

Description

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.

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

Keywords

Metastatic Pancreatic Ductal Adenocarcinoma, Quemliclustat, CD73 Inhibitor, Treatment naive, Pancreatic cancer, PRISM-1, Adenocarcinoma, Paclitaxel, Gemcitabine, Nab-paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCLA Health - Santa Monica Cancer Care accepting new patients
    Santa Monica California 90404 United States
  • Keck Medicine of USC - Keck Hospital of USC accepting new patients
    Los Angeles California 90033-5315 United States
  • Cancer & Blood Specialty Clinic - Los Alamitos accepting new patients
    Los Alamitos California 90720 United States

Lead Scientist at UCLA

  • Zev A. Wainberg, MD
    Zev Wainberg, M.D., holds the Estelle, Abe, and Marjorie Sanders Chair in Cancer Research.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
Links
PRISM-1 - Public website Sign up for this study
ID
NCT06608927
Phase
Phase 3 Pancreatic Ductal Adenocarcinoma Research Study
Study Type
Interventional
Participants
Expecting 610 study participants
Last Updated