← Back to searchRecruitingRecruiting
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
NCT05968326 · Genentech, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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 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 design
Enrollment target: 260 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-18
Estimated completion: 2031-01-01
Last updated: 2026-04-13
Interventions
Drug: Autogene cevumeranDrug: AtezolizumabDrug: mFOLFIRINOX
Primary outcomes
- • Disease Free Survival (DFS) (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)
Sponsor
Genentech, Inc. · industry
With: BioNTech SE
Contacts & investigators
ContactReference Study ID Number: GO44479 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (89)
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
USC Norris Cancer CenterRecruiting
Newport Beach, California, United States
University of California, San Francisco (UCSF)Recruiting
San Francisco, California, United States
University of California Los AngelesRecruiting
Santa Monica, California, United States
St. Francis Hospital and Medical CenterRecruiting
Hartford, Connecticut, United States
Smilow Cancer CenterWithdrawn
New Haven, Connecticut, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at TrumbullRecruiting
Trumbull, Connecticut, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
Indiana University Health Melvin & Bren Simon Cancer CenterRecruiting
Indianapolis, Indiana, United States
University of Kentucky Medical CenterRecruiting
Lexington, Kentucky, United States
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer CenterRecruiting
Boston, Massachusetts, United States
Boston Medical Center (BMC) - Cancer Care CenterRecruiting
Boston, Massachusetts, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
University of NebraskaRecruiting
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center Basking RidgeRecruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer CenterRecruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center at BergenRecruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center - CommackRecruiting
Commack, New York, United States
Memorial Sloan Kettering Cancer Center at WestchesterRecruiting
Harrison, New York, United States
Northwell HealthRecruiting
Lake Success, New York, United States
NYU Langone HealthRecruiting
New York, New York, United States
Mount SInai Medical CenterRecruiting
New York, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHHRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer Center at NassauRecruiting
Uniondale, New York, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
University of Cincinnati Cancer InstituteRecruiting
Cincinnati, Ohio, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
Miriam HospitalRecruiting
Providence, Rhode Island, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
ULB Hôpital ErasmeRecruiting
Brussels, Belgium
Antwerp University HospitalRecruiting
Edegem, Belgium
AZ Maria MiddelaresRecruiting
Ghent, Belgium
Universitair Ziekenhuis GentRecruiting
Ghent, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
St Michael HospitalRecruiting
Toronto, Ontario, Canada
Princess Margaret Cancer CenterRecruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pitalRecruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Centre Hospitalier Régional Universitaire de LilleRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
Institut Paoli CalmettesRecruiting
Marseille, France
Institut de Cancérologie de LorraineRecruiting
Vandœuvre-lès-Nancy, France
Gustave RoussyRecruiting
Villejuif, France
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)Recruiting
Berlin, Germany
Katholisches Klinikum Bochum gGmbH;St. Josef-HospitalRecruiting
Bochum, Germany
Universitaetsklinikum KoelnRecruiting
Cologne, Germany
Universitätsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Universitätsklinikum EssenRecruiting
Essen, Germany
Krankenhaus Nordwest GmbHRecruiting
Frankfurt, Germany
Universitätsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany
Universitaetsklinikum HeidelbergRecruiting
Heidelberg, Germany
Ludwig-Maximilians-Universität MünchenRecruiting
München, Germany
Klinikum BogenhausenRecruiting
München, Germany
Universitaetsklinikum TuebingenRecruiting
Tübingen, Germany
Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III StudienzentraleRecruiting
Ulm, Germany
Uniklinikum Würzburg, Med. Klinik und Poliklinik IIRecruiting
Würzburg, Germany
Amsterdam UMC Location VUMCRecruiting
Amsterdam, Netherlands
UMC Radboud NijmegenRecruiting
Nijmegen, Netherlands
Erasmus MCRecruiting
Rotterdam, Netherlands
National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary CancerRecruiting
Goyang-si, South Korea
CHA Bundang Medical CenterRecruiting
Gyeonggi-do, South Korea
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)Recruiting
Seocho, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Severance Hospital - Yonsei Cancer CenterRecruiting
Seoul, South Korea
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)Recruiting
Songpa-gu, South Korea
Institut Catala d?Oncologia Hospital Germans Trias i PujolRecruiting
Badalona, Barcelona, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Malaga, Spain
Clinica Universitaria de Navarra (CUN)Recruiting
Pamplona/iruña, Navarre, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Principality of Asturias, Spain
Hospital Universitario Vall d HebronRecruiting
Barcelona, Spain
Hospital General Universitario Gregorio MarañonRecruiting
Madrid, Spain
Clinica Universitaria de Navarra de Madrid;Servicio de HepatologiaRecruiting
Madrid, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 De OctubreRecruiting
Madrid, Spain
Centro Integral Oncológico Clara Campal Ensayos Clínicos STARTRecruiting
Madrid, Spain
Sahlgrenska UniversitetssjukhusetRecruiting
Gothenburg, Sweden
Karolinska UniversitetssjukhusetRecruiting
Solna, Sweden
Belfast City HospitalRecruiting
Belfast, United Kingdom
University Hospitals Birmingham NHS Foundation TrustRecruiting
Birmingham, United Kingdom
Addenbrookes HospitalRecruiting
Cambridge, United Kingdom
Royal Liverpool University HospitalRecruiting
Liverpool, United Kingdom
Barts Health NHS TrustRecruiting
London, United Kingdom
Guys HospitalRecruiting
London, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith HospitalRecruiting
London, United Kingdom
University College London Cancer InstituteRecruiting
London, United Kingdom