A Phase 2 Study of an mRNA Vaccine plus Immunotherapy and Chemotherapy Versus Chemotherapy Alone for People with Operable Pancreatic Cancer

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

Purpose

In this study, researchers want to see how well a personalized vaccine works for people with pancreatic cancer. The people in this study have pancreatic cancer that can be taken out with surgery. The vaccine is called autogene cevumeran. It is an “mRNA vaccine,” made in a way similar to the vaccines used to prevent COVID. It will be given in combination with a drug called atezolizumab and a chemotherapy treatment called mFOLFIRINOX.

Autogene cevumeran is made from a person’s own tumor cells. Researchers will collect a sample of cells from a tumor and send it to a lab. There the cells will be genetically analyzed. Based on the genetic analysis of each patient’s tumor, an individual mRNA vaccine will be made for each patient. The mRNA vaccine is designed to help train the immune system to recognize and attack each patient’s own pancreatic cancer cells.

Atezolizumab is a form of immunotherapy. It takes the brakes off the immune response, allowing the immune system to find and kill cancer cells. mFOLFIRINOX is a standard pancreatic cancer treatment. It is a combination of the drugs folinic acid, 5-fluorouracil, irinotecan, and oxaliplatin.

All of the treatments used in this study are given intravenously (by vein). If you join this study, you will be randomly assigned to get one of these treatments:

• The autogene cevumeran vaccine plus atezolizumab and standard mFOLFIRINOX chemotherapy
• Standard chemotherapy with mFOLFIRINOX alone

See clinicaltrials.gov summary

Who Can Join

To join this study, there are a few conditions. You must:

• Have pancreatic cancer that can be removed with surgery.
• Not have had prior chemotherapy, immunotherapy, or radiation therapy for pancreatic cancer.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Vinod Balachandran’s office at 212-639-5785.