A Phase 3 Study of Chemotherapy With and Without Quemliclustat in People With Untreated Metastatic Pancreatic Cancer

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Full 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 (WCG IRB)

Purpose

This study is comparing two treatment regimens for advanced pancreatic cancer. The people in this study have pancreatic ductal adenocarcinoma that has metastasized (spread). They have not yet had treatment for advanced disease.

If you take part in this study, you will be randomly assigned to get one of these treatments:

  • Quemliclustat plus standard chemotherapy (gemcitabine and nab-paclitaxel). Two-thirds of participants will get this therapy.
  • Standard chemotherapy plus a placebo (inactive drug). One-third of patients will get this therapy.

Quemliclustat is designed to help stop cancer cells from growing by blocking an enzyme called CD73. The medications used in this study are all given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic pancreatic ductal adenocarcinoma and not received treatment for advanced disease.
  • Completed any prior therapy for pancreatic cancer at least 1 year before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Alice Zervoudakis’s office at 914-367-7368.

Protocol

25-148

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06608927