Phase
Condition
Adenocarcinoma
Treatment
Autogene cevumeran
Atezolizumab
mFOLFIRINOX
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
ULB Hôpital Erasme
Brussels, 1070
BelgiumActive - Recruiting
Antwerp University Hospital
Edegem, 2650
BelgiumActive - Recruiting
AZ Maria Middelares
Gent, 9000
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
St Michael Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
St Michael Hospital; Hematology and Oncology
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0A9
CanadaActive - Recruiting
Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
FranceActive - Recruiting
Centre Leon Berard
Lyon, 69008
FranceActive - Recruiting
Centre Leon Berard; Service Oncologie Medicale
Lyon, 69008
FranceActive - Recruiting
Institut de Cancérologie de Lorraine
Vandoeuvre-Les-Nancy, 54519
FranceActive - Recruiting
Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, 13353
GermanyActive - Recruiting
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)
Bochum, 44791
GermanyActive - Recruiting
Universitätsklinikum Essen
Essen, 45147
GermanyActive - Recruiting
Krankenhaus Nordwest GmbH
Frankfurt, 60488
GermanyActive - Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanyActive - Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
Universitaetsklinikum Tuebingen
Tuebingen, 72076
GermanyActive - Recruiting
National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer
Goyang-si, 410-769
Korea, Republic ofActive - Recruiting
CHA Bundang Medical Center
Gyeonggi-do, 13496
Korea, Republic ofActive - Recruiting
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, 06591
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofActive - Recruiting
Severance Hospital - Yonsei Cancer Center
Seoul, 120-752
Korea, Republic ofActive - Recruiting
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu, 05505
Korea, Republic ofActive - Recruiting
Erasmus MC
Rotterdam, 3000 CA
NetherlandsActive - Recruiting
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
SpainActive - Recruiting
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
Badalona, Barcelona 08916
SpainActive - Recruiting
Hospital Regional Universitario de Malaga
Málaga, Malaga 29010
SpainActive - Recruiting
Clinica Universitaria de Navarra (CUN)
Pamplona/iruña, Navarra 31008
SpainActive - Recruiting
Hospital Universitario Vall d Hebron
Barcelona, 08035
SpainActive - Recruiting
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Madrid, 28050
SpainActive - Recruiting
Clinica Universitaria de Navarra de Madrid; Servicio de Hepatologia; Servicio de Hepatologia
Madrid, 28027
SpainActive - Recruiting
Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia
Madrid, 28027
SpainActive - Recruiting
Hospital Universitario 12 De Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, 41 343
SwedenActive - Recruiting
Sahlgrenska Universitetssjukhuset; Onkology
Gothenburg, 41 343
SwedenActive - Recruiting
Karolinska Universitetssjukhuset
Solna, 171 64
SwedenActive - Recruiting
Karolinska Universitetssjukhuset
Stockholm, 171 76
SwedenSite Not Available
Belfast City Hospital
Belfast, BT9 7AB
United KingdomActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust; QEHB Pharmacy Department
Birmingham, B15 2TH
United KingdomActive - Recruiting
Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Barts Health NHS Trust
London, EC1A 7BE
United KingdomActive - Recruiting
Hammersmith Hospital
London, W12 0HS
United KingdomActive - Recruiting
Hammersmith Hospital; Dept of Oncology
London, W12 0HS
United KingdomActive - Recruiting
University College London Cancer Institute
London, WC1E 6DD
United KingdomActive - Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesActive - Recruiting
University of California Los Angeles
Los Angeles, California 90095
United StatesActive - Recruiting
USC Norris Cancer Center
Newport Beach, California 92663
United StatesActive - Recruiting
USC Norris Cancer Center; USC Oncology Hematology Newport Beach
Newport Beach, California 92663
United StatesActive - Recruiting
University of California, San Francisco (UCSF)
San Francisco, California 94158
United StatesActive - Recruiting
University of California Los Angeles
Santa Monica, California 90404
United StatesSite Not Available
St. Francis Hospital and Medical Center
Hartford, Connecticut 06105
United StatesActive - Recruiting
Smilow Cancer Center
New Haven, Connecticut 06510
United StatesSite Not Available
Yale Cancer Center
New Haven, Connecticut 06520
United StatesActive - Recruiting
Yale Cancer Center; CLINICAL RESEARCH SUPPORT LABORATORY (CRSL)
New Haven, Connecticut 06519
United StatesActive - Recruiting
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut 06611
United StatesActive - Recruiting
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern Memorial Hospital; Division of Gastroenterology and Hepatology
Chicago, Illinois 60611
United StatesActive - Recruiting
Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
University of Kentucky Medical Center
Lexington, Kentucky 40536
United StatesActive - Recruiting
Boston Medical Center (BMC) - Cancer Care Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
Boston, Massachusetts 02114-2621
United StatesActive - Recruiting
Henry Ford Health System
Detroit, Michigan 48202
United StatesActive - Recruiting
University of Nebraska
Omaha, Nebraska 68198-5300
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center; MSK Monmouth
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York 10604
United StatesActive - Recruiting
Northwell Health
Lake Success, New York 11042
United StatesActive - Recruiting
Northwell Health; Monter Cancer Center
Lake Success, New York 11042
United StatesActive - Recruiting
NYU Langone Health
Mineola, New York 11501
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Mount SInai Medical Center
New York, New York 10029
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale, New York 11553
United StatesActive - Recruiting
Duke Cancer Institute
Durham, North Carolina 27705
United StatesActive - Recruiting
University of Cincinnati Cancer Institute
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Miriam Hospital
Providence, Rhode Island 02906
United StatesActive - Recruiting
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesActive - Recruiting
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