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

Last updated: May 26, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Adenocarcinoma

Treatment

Autogene cevumeran

Atezolizumab

mFOLFIRINOX

Clinical Study ID

NCT05968326
GO44479
2022-502404-73-00
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of PDAC

  • Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values ofT1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) CancerStaging 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 randomization

  • 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 pregnancyduring the treatment period and for 28 days after the final dose of autogenecevumeran, for 9 months after the last dose of chemotherapy, and for 5 months afterthe final dose of atezolizumab. They must refrain from donating eggs for 9 monthsafter the last dose of chemotherapy.

  • Male participants with a female partner of childbearing potential or pregnant femalepartner must remain abstinent or use specified contraceptive methods during thetreatment 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 spermduring this same period.

Exclusion

Exclusion Criteria:

  • Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer

  • Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and/orchemotherapy), not mandated per protocol, to be initiated after completion ofmFOLFIRINOX treatment

  • Absence of spleen; distal pancreatectomy with splenectomy is exclusionary

  • Preexisting Grade >/=2 neuropathy

  • Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygousor compound heterozygous mutations of DPYD genetic locus associated with DPDdeficiency

  • 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, whichare 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 Design

Total Participants: 260
Treatment Group(s): 3
Primary Treatment: Autogene cevumeran
Phase: 2
Study Start date:
October 18, 2023
Estimated Completion Date:
December 27, 2029

Connect with a study center

  • ULB Hôpital Erasme

    Brussels, 1070
    Belgium

    Active - Recruiting

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Active - Recruiting

  • AZ Maria Middelares

    Gent, 9000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • St Michael Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • St Michael Hospital; Hematology and Oncology

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Centre hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 59037
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69008
    France

    Active - Recruiting

  • Centre Leon Berard; Service Oncologie Medicale

    Lyon, 69008
    France

    Active - Recruiting

  • Institut de Cancérologie de Lorraine

    Vandoeuvre-Les-Nancy, 54519
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

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

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)

    Bochum, 44791
    Germany

    Active - Recruiting

  • Universitätsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Tuebingen

    Tuebingen, 72076
    Germany

    Active - Recruiting

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

    Goyang-si, 410-769
    Korea, Republic of

    Active - Recruiting

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496
    Korea, Republic of

    Active - Recruiting

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

    Seocho, 06591
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital - Yonsei Cancer Center

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

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

    Songpa-gu, 05505
    Korea, Republic of

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3000 CA
    Netherlands

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, Malaga 29010
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra (CUN)

    Pamplona/iruña, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Centro Integral Oncológico Clara Campal Ensayos Clínicos START

    Madrid, 28050
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra de Madrid; Servicio de Hepatologia; Servicio de Hepatologia

    Madrid, 28027
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41 343
    Sweden

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset; Onkology

    Gothenburg, 41 343
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Solna, 171 64
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Belfast City Hospital

    Belfast, BT9 7AB
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust; QEHB Pharmacy Department

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London, EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital; Dept of Oncology

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • University College London Cancer Institute

    London, WC1E 6DD
    United Kingdom

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • USC Norris Cancer Center

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • USC Norris Cancer Center; USC Oncology Hematology Newport Beach

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • University of California, San Francisco (UCSF)

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of California Los Angeles

    Santa Monica, California 90404
    United States

    Site Not Available

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut 06105
    United States

    Active - Recruiting

  • Smilow Cancer Center

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Yale Cancer Center; CLINICAL RESEARCH SUPPORT LABORATORY (CRSL)

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Smilow Cancer Hospital Care Center at Trumbull

    Trumbull, Connecticut 06611
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital; Division of Gastroenterology and Hepatology

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Indiana University Health Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Boston Medical Center (BMC) - Cancer Care Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

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

    Boston, Massachusetts 02114-2621
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • University of Nebraska

    Omaha, Nebraska 68198-5300
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center; MSK Monmouth

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center at Bergen

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center - Commack

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center at Westchester

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Northwell Health

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Northwell Health; Monter Cancer Center

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • NYU Langone Health

    Mineola, New York 11501
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount SInai Medical Center

    New York, New York 10029
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center at Nassau

    Uniondale, New York 11553
    United States

    Active - Recruiting

  • Duke Cancer Institute

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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