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Adenocarcinoma, Pancreatic DuctalPhase 2IMCODE003NCT05968326

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 2 study testing Autogene cevumeran, Atezolizumab and mFOLFIRINOX in people with Adenocarcinoma, Pancreatic Ductal, run by Genentech, Inc. at 87 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma, Pancreatic Ductal
What is being tested?
Autogene cevumeran, Atezolizumab and mFOLFIRINOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
87 sitesin 10 countries
Study dates
18 Oct 2023to 1 Jan 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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).

Trial locations and contacts

87 sites in 10 countries.

87 sites in 10 countries

United States30 sites

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center

    Boston, Massachusetts, 02114-2621

  • Boston Medical Center (BMC) - Cancer Care Center

    Boston, Massachusetts, 02118

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45219

  • Memorial Sloan Kettering Cancer Center - Commack

    Commack, New York, 11725

  • Henry Ford Health System

    Detroit, Michigan, 48202-2610

  • Duke Cancer Institute

    Durham, North Carolina, 27710-4000

  • Memorial Sloan Kettering Cancer Center at Westchester

    Harrison, New York, 10604

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Indiana University Health Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Northwell Health

    Lake Success, New York, 11042

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Memorial Sloan Kettering Cancer Center

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center at Bergen

    Montvale, New Jersey, 07645

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Mount SInai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH

    New York, New York, 10065-7471

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • USC Norris Cancer Center

    Newport Beach, California, 92663

  • University of Nebraska

    Omaha, Nebraska, 68198-5300

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94158-2350

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Smilow Cancer Hospital Care Center at Trumbull

    Trumbull, Connecticut, 06611

  • Memorial Sloan Kettering Cancer Center at Nassau

    Uniondale, New York, 11553

Other trials in United States

Germany13 sites

  • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    Berlin, 13353

  • Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital

    Bochum, 44791

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Essen

    Essen, 45122

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Ludwig-Maximilians-Universität München

    München, 81377

  • Klinikum Bogenhausen

    München, 81925

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale

    Ulm, 89081

  • Uniklinikum Würzburg, Med. Klinik und Poliklinik II

    Würzburg, 97080

Other trials in Germany

Spain10 sites

  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall d Hebron

    Barcelona, 08035

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia

    Madrid, 28027

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

  • Centro Integral Oncológico Clara Campal Ensayos Clínicos START

    Madrid, 28050

  • Hospital Regional Universitario de Malaga

    Málaga, Malaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Clinica Universitaria de Navarra (CUN)

    Pamplona/iruña, Navarre, 31008

Other trials in Spain

United Kingdom8 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Clatterbridge Cancer Centre Liverpool

    Liverpool, LIV, L7 8YA

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Guys Hospital

    London, SE1 9RT

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London, W12 0HS

  • University College London Cancer Institute

    London, WC1E 6DD

Other trials in United Kingdom

South Korea7 sites

  • National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer

    Goyang-si, 410-769

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)

    Seocho, 06591

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Samsung Medical Center

    Seoul, 06351

  • Severance Hospital - Yonsei Cancer Center

    Seoul, 120-752

  • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

    Songpa-gu, 05505

Other trials in South Korea

Belgium5 sites

  • ULB Hôpital Erasme

    Brussels, 1070

  • Antwerp University Hospital

    Edegem, VAN, 2650

  • AZ Maria Middelares

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

France5 sites

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13273

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Canada4 sites

  • Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital

    Montreal, Quebec, H2L 4M1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St Michael Hospital

    Toronto, Ontario, M5B 1W8

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands3 sites

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV

  • UMC Radboud Nijmegen

    Nijmegen, 6500 HB

  • Erasmus MC

    Rotterdam, 3000 CA

Other trials in Netherlands

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41 343

  • Karolinska Universitetssjukhuset

    Solna, 171 64

Other trials in Sweden

About this study

Official title: 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.

Being tested
Autogene cevumeran, Atezolizumab, mFOLFIRINOX
Medical subject headings
Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autogene cevumeranDrug

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

  • AtezolizumabDrug

    Also called Tecentriq

    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.

Study groups in NCT05968326
Study groupRoleWhat they receive
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOXExperimentalParticipants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
Receives: Drug: Autogene cevumeran; Drug: Atezolizumab; Drug: mFOLFIRINOX
Arm 2: mFOLFIRINOXActive comparatorParticipants will receive mFOLFIRINOX.
Receives: Drug: mFOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival (DFS)

    Measured: 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 outcomes (4)

  1. DFS Rates at 12, 24, and 36 Months

    Measured: Months 12, 24, 36

  2. Overall Survival (OS)

    Measured: From randomization to death from any cause (up to approximately 6 years)

  3. OS Rates at 3 and 5 Years

    Measured: Years 3 and 5

  4. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start18 Oct 2023
  3. Primary completion1 Jan 2031 (estimated)
  4. Study completion1 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05968326
Sponsor's protocol ID
GO44479
Other IDs
2022-502404-73-00
Acronym
IMCODE003
Status last verified
Sep 2026
First submitted
21 Jul 2023
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autogene cevumeran, Atezolizumab and mFOLFIRINOX in people with Adenocarcinoma, Pancreatic Ductal, run by Genentech, Inc. at 87 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Germany, Spain, United Kingdom, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05968326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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