Recruiting

IMCODE003Autogene Cevumeran, Atezolizumab and mFOLFIRINOX for Resected Pancreatic Ductal Adenocarcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This phase 2 study aims to evaluate the effectiveness of Autogene Cevumeran, Atezolizumab and mFOLFIRINOX as a treatment for resected Pancreatic Ductal Adenocarcinoma, focusing on Disease Free Survival.

What is being tested

Autogene cevumeran

+ Atezolizumab

+ mFOLFIRINOX

Drug
Who is being recruted

Adenocarcinoma+2

+ Carcinoma

+ Neoplasms

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2023
See protocol details

Summary

Principal SponsorGenentech, Inc.
Study ContactReference Study ID Number: GO44479 https://forpatients.roche.com/
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 18, 2023

Actual date on which the first participant was enrolled.

This is a Phase 2 study focusing on treating pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. The study is designed for patients who have had their tumor surgically removed and have not received any prior systemic anti-cancer treatment for PDAC. The main goal is to compare the effectiveness and safety of a combination therapy (autogene cevumeran plus atezolizumab and mFOLFIRINOX) against mFOLFIRINOX alone. This research is important as it aims to find a better treatment approach for PDAC, potentially improving patient care and outcomes. During the study, participants are randomly assigned to one of two treatment groups. One group receives the combination therapy, which includes autogene cevumeran, atezolizumab, and a chemotherapy regimen called mFOLFIRINOX. The other group receives only mFOLFIRINOX. The primary outcome measured is Disease Free Survival (DFS), which indicates how long patients live without their cancer returning.

Official TitleA 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
NCT05968326
Principal SponsorGenentech, Inc.
Study ContactReference Study ID Number: GO44479 https://forpatients.roche.com/
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

260 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial

Criteria

2 inclusion criteria required to participate
Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 28 days after the final dose of autogene cevumeran, for 9 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab. They must refrain from donating eggs for 9 months after the last dose of chemotherapy
Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period
3 exclusion criteria prevent from participating
Preexisting Grade >= 2 neuropathy
Disorders of the colon or rectum, or postoperative complication leading to Grade >= 2 diarrhea
Current or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and/or uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

Group II

Active Comparator
Participants will receive mFOLFIRINOX.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 89 locations

Recruiting

USC Norris Comprehensive Cancer Center

Los Angeles, United StatesOpen USC Norris Comprehensive Cancer Center in Google Maps
Recruiting

USC Norris Cancer Center

Newport Beach, United States
Recruiting

University of California, San Francisco (UCSF)

San Francisco, United States
Recruiting

University of California Los Angeles

Santa Monica, United States
Recruiting
89 Study Centers