Purpose of this Study
We are doing this study to compare 2 different regimens for treating pancreatic cancer after surgery. We what find out how well patients do after they get a combination of the drugs cevumeran, atezolizumab, and mFOLFIRINOX compared to just getting mFOLFIRINOX alone. Cevumeran is an experimental drug that is made from your own cells that are obtained from blood and tissue samples. It is designed to activate your immune system against cancer cells in your body.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with pancreatic cancer
- Are able to have surgery to remove the cancer
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to either:
- Get the combination of autogene cevumeran plus atezolizumab and mFOLFIRINOX; OR
- Get mFOLFIRINOX alone
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
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
Principal Investigator
Daniel
Nussbaum
Protocol Number
PRO00113749
NCT ID
NCT05968326
Phase
II
Enrollment Status
Open to Enrollment