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
Summary
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.
Arms & interventions
- DrugAutogene cevumeran
Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
- DrugAtezolizumab
Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
- DrugmFOLFIRINOX
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Outcome measures
Primary
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
Secondary
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
Eligibility criteria
Study locations (32)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
USC Norris Cancer Center
Newport Beach, California, 92663
University of California, San Francisco (UCSF)
San Francisco, California, 94158-2350
University of California Los Angeles
Santa Monica, California, 90404
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Smilow Cancer Center
New Haven, Connecticut, 06510
Yale Cancer Center
New Haven, Connecticut, 06520
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut, 06611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
Boston, Massachusetts, 02114-2621
Boston Medical Center (BMC) - Cancer Care Center
Boston, Massachusetts, 02118
Henry Ford Health System
Detroit, Michigan, 48202-2610
University of Nebraska
Omaha, Nebraska, 68198-5300
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604
Northwell Health
Lake Success, New York, 11042
NYU Langone Health
New York, New York, 10016
Mount SInai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH
New York, New York, 10065-7471
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale, New York, 11553
Duke Cancer Institute
Durham, North Carolina, 27710-4000
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219
Rhode Island Hospital
Providence, Rhode Island, 02903
Miriam Hospital
Providence, Rhode Island, 02906
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109