NCT05968326

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-10-18
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2023-08-01
• Last updated: 2026-04-13

Locations

89 sites across 10 countries: United States, Belgium, Canada, France, Germany, Netherlands, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study