A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ADJUVANT AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS mFOLFIRINOX ALONE IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA

Contact:

NCT Number:

Protocol:

AAAU5427

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II

The purpose of this study is to compare the effects, good or bad, of autogene cevumeran plus atezolizumab and mFOLFIRINOX compared with mFOLFIRINOX (standard of care chemotherapy) alone on patients with resected pancreatic ductal adenocarcinoma (PDAC). In this study, the participant will get either the combination of autogene cevumeran plus atezolizumab and mFOLFIRINOX or mFOLFIRINOX alone. Autogene cevumeran is a personalized drug product that will be made specifically for the participant and is designed to activate and train your immune system to find and kill cancer cells. Autogene cevumeran is an experimental drug, which means health authorities including the U.S. Food and Drug Administration (FDA) have not approved autogene cevumeran alone or in combination with atezolizumab and mFOLFIRINOX for the treatment of PDAC after surgical resection.

Are you Eligible? (Inclusion Criteria)

  • You must have been diagnosed with respectable (able to surgically removed) pancreatic ductal adenocarcinoma (PDAC). - You must be willing to have the study drug administered intravenously (through vein in your arm) - You must be at lest 18 years of age

Specialty Area(s)

Pancreatic Cancer, Immunotherapy

Principal Investigator

Profile Headshot
  • Director of Gastrointestinal Oncology
  • Director of Pancreas Translational Research
  • Co-Director of The Pancreas Center

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032