CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 260 target
Drug / intervention
Autogene cevumeran +2 moredrug
Likely dose
Atezolizumab 1680 milligramsfrom record
Key inclusion· 8
  • ✓Histologically confirmed PDAC diagnosis
  • ✓TNM staging T1-T3, N0-N2, M0 per AJCC
  • ✓Macroscopically complete resection (R0 or R1)
  • ✓No evidence of disease after surgery within 28 days
Key exclusion· 10
  • ✕Prior adjuvant, neoadjuvant, or induction therapy for pancreatic cancer
  • ✕Plan for further adjuvant anti-cancer therapy not mandated by protocol
  • ✕Absence of spleen; distal pancreatectomy with splenectomy exclusionary
  • ✕Preexisting Grade ≥2 neuropathy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05968326
NCT05968326Phase 2RecruitingOn Track
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Aug 1, 2023·Updated Jun 9, 2026

In Brief

A Phase 2 clinical trial evaluating Autogene cevumeran, Atezolizumab, and 1 other intervention for Adenocarcinoma, Pancreatic Ductal. Currently recruiting, targeting 260 participants across 89 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma, Pancreatic Ductal
CountriesBelgium, Canada, France, Germany, Netherlands, South Korea, Spain, Sweden, United Kingdom, United States
CollaboratorsBioNTech SE

Timeline

Phase 2Recruiting
20242025202620272028202920302031
First PostedAug 1, 2023
Enrollment StartOct 18, 2023
Primary CompletionJan 1, 2031
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 2.9 years agoPrimary completion in 4.5 years

Arms & Interventions

Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOXexperimental

Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

Drug: Autogene cevumeranDrug: AtezolizumabDrug: mFOLFIRINOX
Arm 2: mFOLFIRINOXactive_comparator

Participants will receive mFOLFIRINOX.

Drug: mFOLFIRINOX

Interventions

Autogene cevumerandrug

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

Atezolizumabdrug

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

mFOLFIRINOXdrug

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