GO44479
Research type
Research Study
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
IRAS ID
1007939
Contact name
Eric Olsen
Contact email
Sponsor organisation
Genentech, Inc.
Clinicaltrials.gov Identifier
Research summary
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.REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0820
Date of REC Opinion
4 Jan 2024
REC opinion
Further Information Favourable Opinion