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
Categories (click each to see list of all clinical trials associated with that category): GI (ONC), Pancreatic Cancer Center of Excellence - PCCE (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Krishnan, Mridula
Contact Information:
Kate Roth
kateroth@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05968326?term=NCT05968326&rank=1#participation-criteria
Summary
Primary Objectives:
To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX by disease-free survival (DFS)
Secondary Objectives:
1. To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX in Overall Survival (OS)
2. To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX by disease-free survival (DFS) rates at 12, 24 and 36 months and OS at 3 and 5 years
3. To evaluate the safety of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX by disease-free survival (DFS)