Active Cancer NIHR-supported project Digestion, Kidneys & Other Organs

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR Barts Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Feb 2025 — Feb 2031

In plain English

AI plain-English summary

Most patients who have pancreatic cancer surgically removed still see the disease return within a few years. This trial tests whether adding a personalised vaccine and an immunotherapy drug to standard chemotherapy can keep that from happening. The problem is stark: pancreatic ductal adenocarcinoma (PDAC) is notoriously aggressive, and even after successful surgery and chemotherapy, recurrence rates remain high. Current standard-of-care leaves most patients with a poor outlook. This trial directly addresses that gap by combining three approaches—a custom-made vaccine (autogene cevumeran) built from each patient’s own tumour tissue, an immune-boosting drug (atezolizumab), and standard chemotherapy (mFOLFIRINOX)—against chemotherapy alone. If the experimental combination proves more effective, it could transform post-surgery care for PDAC. Instead of a one-size-fits-all chemotherapy that often fails, patients would receive a treatment tailored to their individual cancer, designed to train their immune system to hunt down residual tumour cells. Around 260 participants will be followed for up to six years. The study is sponsored by Genentech.

View original technical description
This clinical trial addresses an important need to identify improved post-surgery therapies for people with a type of cancer of the pancreas called pancreatic ductal adenocarcinoma (PDAC). The majority of patients who have their PDAC removed (resected) and receive current standard-of-care chemotherapy either experience their disease coming back (recurrence) or die from their disease despite this aggressive therapy. This clinical trial aims to compare the effects of an individualised drug product (autogene cevumeran) given in combination with an immunotherapy (atezolizumab) and chemotherapy (mFOLFIRINOX), compared to chemotherapy alone, as post-surgery therapy in people with resected PDAC.People who take part in this clinical trial will be given either the experimental treatment, autogene cevumeran in combination with atezolizumab and mFOLFIRINOX, or standard-of-care post-surgery therapy, mFOLFIRINOX.Autogene cevumeran will be made specifically for each participant from their tumour tissue, routinely collected at surgery, and their blood samples. It is designed to activate and train the immune system to find and kill cancer cells. Atezolizumab is a drug designed to help the immune system kill cancer cells.Clinic visits will include treatment and checks to see how the participant responds to the treatment and any side effects that may occur. The total time of participation in the clinical trial is expected to range from 1 day to more than 6 years. About 260 people will take part in this study. The study is sponsored by Genentech, Inc.

Researchers

Marco Gerlinger (Principal Investigator)

Related Research

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A phase 2, 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
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Original classification

Precision Cancer Care

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.