Autogene Cevumeran plus Atezolizumab and mFolfirinox vs mFolfirinox alone (Pancreatic Cancer)

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:<ul>
<li>Are diagnosed with pancreatic cancer</li>
<li>Are able to have surgery to remove the cancer</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: jennifer.gallagher@duke.edu"> jennifer.gallagher@duke.edu.</a>

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?

If you choose to join this study, you will get a random assignment (like a coin flip) to either:<ul>
<li>Get the combination of autogene cevumeran plus atezolizumab and mFOLFIRINOX; OR</li>
<li>Get mFOLFIRINOX alone</li></ul>

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
ClinicalTrials.gov