A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC (IMCODE003)

May 8, 2026 updated by: Genentech, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • ULB Hopital Erasme
      • Ghent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
      • Ghent, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
    • VAN
      • Edegem, VAN, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Center
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St Michael Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2L 4M1
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
  • France
      • Lille, France, 59037
        • Recruiting
        • Centre Hospitalier Regional Universitaire de Lille
      • Lyon, France, 69008
        • Recruiting
        • Centre Léon Bérard
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Institut de Cancerologie de Lorraine
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
      • Bochum, Germany, 44791
        • Recruiting
        • Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital
      • Cologne, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Essen, Germany, 45122
        • Recruiting
        • Universitätsklinikum Essen
      • Frankfurt, Germany, 60488
        • Recruiting
        • Krankenhaus Nordwest GmbH
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
      • München, Germany, 81377
        • Recruiting
        • Ludwig-Maximilians-Universität München
      • München, Germany, 81925
        • Recruiting
        • Klinikum Bogenhausen
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, 89081
        • Recruiting
        • Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale
      • Würzburg, Germany, 97080
        • Recruiting
        • Uniklinikum Würzburg, Med. Klinik und Poliklinik II
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC Location VUMC
      • Nijmegen, Netherlands, 6500 HB
        • Recruiting
        • UMC Radboud Nijmegen
      • Rotterdam, Netherlands, 3000 CA
        • Recruiting
        • Erasmus Mc
  • South Korea
      • Goyang-si, South Korea, 410-769
        • Recruiting
        • National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer
      • Gyeonggi-do, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center
      • Seocho, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 120-752
        • Recruiting
        • Severance Hospital - Yonsei Cancer Center
      • Songpa-gu, South Korea, 05505
        • Recruiting
        • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d Hebron
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Recruiting
        • Centro Integral Oncológico Clara Campal Ensayos Clínicos START
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Institut Catala d?Oncologia Hospital Germans Trias i Pujol
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
    • Navarre
      • Pamplona/iruña, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universitaria de Navarra (CUN)
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central De Asturias
  • Sweden
      • Gothenburg, Sweden, 41 343
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
      • Solna, Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Recruiting
        • Belfast City Hospital
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrookes Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Royal Liverpool University Hospital
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Barts Health NHS Trust
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guys Hospital
      • London, United Kingdom, WC1E 6DD
        • Recruiting
        • University College London Cancer Institute
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
      • Newport Beach, California, United States, 92663
        • Recruiting
        • USC Norris Cancer Center
      • San Francisco, California, United States, 94158-2350
        • Recruiting
        • University of California, San Francisco (UCSF)
      • Santa Monica, California, United States, 90404
        • Recruiting
        • University of California Los Angeles
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • St. Francis Hospital and Medical Center
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale Cancer Center
      • New Haven, Connecticut, United States, 06510
        • Withdrawn
        • Smilow Cancer Center
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center at Trumbull
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Melvin & Bren Simon Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2621
        • Recruiting
        • Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center (BMC) - Cancer Care Center
    • Michigan
      • Detroit, Michigan, United States, 48202-2610
        • Recruiting
        • Henry Ford Health System
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5300
        • Recruiting
        • University of Nebraska
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Cancer Center Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Cancer Center at Bergen
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Commack
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Cancer Center at Westchester
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
      • New York, New York, United States, 10016
        • Active, not recruiting
        • NYU Langone Health
      • New York, New York, United States, 10065-7471
        • Recruiting
        • MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Cancer Center at Nassau
    • North Carolina
      • Durham, North Carolina, United States, 27710-4000
        • Recruiting
        • Duke Cancer Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Miriam Hospital
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of PDAC
  • Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
  • Macroscopically complete (R0 or R1) resection of PDAC
  • Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to treatment initiation
  • CA19-9 level measured within 14 days prior to initiation of study treatment
  • Interval of between 6 and 12 weeks since resection of PDAC
  • Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
  • Adequate hematologic and end-organ function
  • 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.

Exclusion Criteria:

  • Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
  • Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and/or chemotherapy), not mandated per protocol, to be initiated after completion of mFOLFIRINOX treatment
  • Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
  • Preexisting Grade >/=2 neuropathy
  • Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygous or compound heterozygous mutations of DPYD genetic locus associated with DPD deficiency
  • Disorders of the colon or rectum, or postoperative complication leading to Grade >/=2 diarrhea
  • Pregnancy or breastfeeding
  • Active or history of autoimmune disease or immune deficiency
  • Treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of DPD, within 4 weeks prior to initiation of study treatment
  • Current or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and/or uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1).

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
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.
Other Names:
  • Tecentriq
Drug: mFOLFIRINOX
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Active Comparator: Arm 2: mFOLFIRINOX
Participants will receive mFOLFIRINOX.
Drug: mFOLFIRINOX
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Free Survival (DFS)
Time Frame: From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years
From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
DFS Rates at 12, 24, and 36 Months
Time Frame: Months 12, 24, 36
Months 12, 24, 36
Overall Survival (OS)
Time Frame: From randomization to death from any cause (up to approximately 6 years)
From randomization to death from any cause (up to approximately 6 years)
OS Rates at 3 and 5 Years
Time Frame: Years 3 and 5
Years 3 and 5
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 6 years
Up to approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

BioNTech SE

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO44479
  • 2022-502404-73-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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