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

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.

Interventions

• Autogene cevumeran · DRUG

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

• Atezolizumab · DRUG

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

• mFOLFIRINOX · DRUG

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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).

Sites (89)

• USC Norris Comprehensive Cancer Center, Los Angeles, California · RECRUITING
• USC Norris Cancer Center, Newport Beach, California · RECRUITING
• University of California, San Francisco (UCSF), San Francisco, California · RECRUITING
• University of California Los Angeles, Santa Monica, California · RECRUITING
• St. Francis Hospital and Medical Center, Hartford, Connecticut · RECRUITING
• Smilow Cancer Center, New Haven, Connecticut · WITHDRAWN
• Yale Cancer Center, New Haven, Connecticut · RECRUITING
• Smilow Cancer Hospital Care Center at Trumbull, Trumbull, Connecticut · RECRUITING
• Northwestern Memorial Hospital, Chicago, Illinois · RECRUITING
• Indiana University Health Melvin & Bren Simon Cancer Center, Indianapolis, Indiana · RECRUITING
• University of Kentucky Medical Center, Lexington, Kentucky · RECRUITING
• Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center, Boston, Massachusetts · RECRUITING
• Boston Medical Center (BMC) - Cancer Care Center, Boston, Massachusetts · RECRUITING
• Henry Ford Health System, Detroit, Michigan · RECRUITING
• University of Nebraska, Omaha, Nebraska · RECRUITING
• Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey · RECRUITING
• Memorial Sloan Kettering Cancer Center, Middletown, New Jersey · RECRUITING
• Memorial Sloan Kettering Cancer Center at Bergen, Montvale, New Jersey · RECRUITING
• Memorial Sloan Kettering Cancer Center - Commack, Commack, New York · RECRUITING
• Memorial Sloan Kettering Cancer Center at Westchester, Harrison, New York · RECRUITING
• Northwell Health, Lake Success, New York · RECRUITING
• NYU Langone Health, New York, New York · ACTIVE_NOT_RECRUITING
• Mount SInai Medical Center, New York, New York · RECRUITING
• Columbia University Medical Center, New York, New York · RECRUITING
• MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH, New York, New York · RECRUITING
• Memorial Sloan Kettering Cancer Center, New York, New York · RECRUITING
• Memorial Sloan Kettering Cancer Center at Nassau, Uniondale, New York · RECRUITING
• Duke Cancer Institute, Durham, North Carolina · RECRUITING
• University of Cincinnati Cancer Institute, Cincinnati, Ohio · RECRUITING
• Rhode Island Hospital, Providence, Rhode Island · RECRUITING
• Miriam Hospital, Providence, Rhode Island · RECRUITING
• Fred Hutchinson Cancer Research Center, Seattle, Washington · RECRUITING
• Antwerp University Hospital, Edegem, VAN, Belgium · RECRUITING
• ULB Hôpital Erasme, Brussels, Belgium · RECRUITING
• AZ Maria Middelares, Ghent, Belgium · RECRUITING
• Universitair Ziekenhuis Gent, Ghent, Belgium · RECRUITING
• UZ Leuven, Leuven, Belgium · RECRUITING
• St Michael Hospital, Toronto, Ontario, Canada · RECRUITING
• Princess Margaret Cancer Center, Toronto, Ontario, Canada · RECRUITING
• Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital, Montreal, Quebec, Canada · RECRUITING
• Jewish General Hospital, Montreal, Quebec, Canada · RECRUITING
• Centre Hospitalier Régional Universitaire de Lille, Lille, France · RECRUITING
• Centre Leon Berard, Lyon, France · RECRUITING
• Institut Paoli Calmettes, Marseille, France · RECRUITING
• Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France · RECRUITING
• Gustave Roussy, Villejuif, France · RECRUITING
• Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK), Berlin, Germany · RECRUITING
• Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital, Bochum, Germany · RECRUITING
• Universitaetsklinikum Koeln, Cologne, Germany · RECRUITING
• Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany · RECRUITING
• Universitätsklinikum Essen, Essen, Germany · RECRUITING
• Krankenhaus Nordwest GmbH, Frankfurt, Germany · RECRUITING
• Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany · RECRUITING
• Universitaetsklinikum Heidelberg, Heidelberg, Germany · RECRUITING
• Ludwig-Maximilians-Universität München, München, Germany · RECRUITING
• Klinikum Bogenhausen, München, Germany · RECRUITING
• Universitaetsklinikum Tuebingen, Tübingen, Germany · RECRUITING
• Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale, Ulm, Germany · RECRUITING
• Uniklinikum Würzburg, Med. Klinik und Poliklinik II, Würzburg, Germany · RECRUITING
• Amsterdam UMC Location VUMC, Amsterdam, Netherlands · RECRUITING
• UMC Radboud Nijmegen, Nijmegen, Netherlands · RECRUITING
• Erasmus MC, Rotterdam, Netherlands · RECRUITING
• National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer, Goyang-si, South Korea · RECRUITING
• CHA Bundang Medical Center, Gyeonggi-do, South Korea · RECRUITING
• The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital), Seocho, South Korea · RECRUITING
• Seoul National University Bundang Hospital, Seongnam-si, South Korea · RECRUITING
• Samsung Medical Center, Seoul, South Korea · RECRUITING
• Severance Hospital - Yonsei Cancer Center, Seoul, South Korea · RECRUITING
• University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC), Songpa-gu, South Korea · RECRUITING
• Institut Catala d?Oncologia Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain · RECRUITING
• Hospital Regional Universitario de Malaga, Málaga, Malaga, Spain · RECRUITING
• Clinica Universitaria de Navarra (CUN), Pamplona/iruña, Navarre, Spain · RECRUITING
• Hospital Universitario Central de Asturias, Oviedo, Principality of Asturias, Spain · RECRUITING
• Hospital Universitario Vall d Hebron, Barcelona, Spain · RECRUITING
• Hospital General Universitario Gregorio Marañon, Madrid, Spain · RECRUITING
• Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia, Madrid, Spain · RECRUITING
• Hospital Universitario Ramón y Cajal, Madrid, Spain · RECRUITING
• Hospital Universitario 12 De Octubre, Madrid, Spain · RECRUITING
• Centro Integral Oncológico Clara Campal Ensayos Clínicos START, Madrid, Spain · RECRUITING
• Sahlgrenska Universitetssjukhuset, Gothenburg, Sweden · RECRUITING
• Karolinska Universitetssjukhuset, Solna, Sweden · RECRUITING
• Clatterbridge Cancer Centre Liverpool, Liverpool, LIV, United Kingdom · RECRUITING
• Belfast City Hospital, Belfast, United Kingdom · RECRUITING
• University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom · RECRUITING
• Addenbrookes Hospital, Cambridge, United Kingdom · RECRUITING
• Barts Health NHS Trust, London, United Kingdom · RECRUITING
• Guys Hospital, London, United Kingdom · RECRUITING
• Imperial College Healthcare NHS Trust - Hammersmith Hospital, London, United Kingdom · RECRUITING
• University College London Cancer Institute, London, United Kingdom · RECRUITING