The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.
Histologically confirmed diagnosis of PDAC
Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
Macroscopically complete (R0 or R1) resection of PDAC
Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to treatment initiation
Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and/or chemotherapy), not mandated per protocol, to be initiated after completion of mFOLFIRINOX treatment
Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
Preexisting Grade >/=2 neuropathy
Genentech, Inc.
Lead sponsor
BioNTech SE
Collaborator