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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUSC Norris Cancer Center
Newport Beach, California, United States
RECRUITINGUniversity of California, San Francisco (UCSF)
San Francisco, California, United States
RECRUITINGUniversity of California Los Angeles
Santa Monica, California, United States
Disease Free Survival (DFS)
Time frame: From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years
DFS Rates at 12, 24, and 36 Months
Time frame: Months 12, 24, 36
Overall Survival (OS)
Time frame: From randomization to death from any cause (up to approximately 6 years)
OS Rates at 3 and 5 Years
Time frame: Years 3 and 5
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 6 years
Reference Study ID Number: GO44479 https://forpatients.roche.com/
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St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
RECRUITINGSmilow Cancer Center
New Haven, Connecticut, United States
WITHDRAWNYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGSmilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut, United States
RECRUITINGNorthwestern Memorial Hospital
Chicago, Illinois, United States
SUSPENDEDIndiana University Health Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITING...and 79 more locations