MedTrace Logo

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

NCT05968326 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-05-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.

Conditions

  • Adenocarcinoma, Pancreatic Ductal

Interventions

DRUG

Autogene cevumeran

Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.

DRUG

Atezolizumab

Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.

DRUG

mFOLFIRINOX

mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2031-01-01
Completion
2031-01-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Netherlands
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968326 on ClinicalTrials.gov