A Phase II, Open-Label, Randomized Study of Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of adding autogene cevumeran and atezolizumab to a chemotherapy regimen called mFOLFIRINOX compared to mFOLFIRINOX alone in patients who have had pancreatic ductal adenocarcinoma PDAC surgically removed. The study focuses on participants who have not previously received systemic treatment for PDAC and show no evidence of disease after surgery. This is a phase II, open-label, randomized trial sponsored by Genentech, Inc. Participants are randomly assigned to one of two groups one group receives autogene cevumeran and atezolizumab along with mFOLFIRINOX chemotherapy, and the other group receives only mFOLFIRINOX. All medications are administered intravenously at specified times. The trial includes monitoring over approximately six years to assess outcomes. During the study, participants will be regularly evaluated for disease recurrence or new cancers, survival, and side effects. The main measure is disease-free survival from randomization to the first recurrence or death. Additional assessments include survival rates at specific time points and monitoring adverse events. Participants will be followed closely with clinical assessments to track their health and response to treatment throughout the study period.

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC