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NCT05968326PHASE2Recruiting

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

Genentech, Inc.

Start Date

10/18/2023

Completion Date

1/1/2031

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

Age Range: 18 years to No maximum

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).

Interventions

DRUG

Autogene cevumeran

DRUG

Atezolizumab

DRUG

mFOLFIRINOX

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Conditions

Adenocarcinoma, Pancreatic Ductal

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

USC Norris Cancer Center

Newport Beach, California 92663

United States

University of California, San Francisco (UCSF)

San Francisco, California 94158-2350

United States

University of California Los Angeles

Santa Monica, California 90404

United States

St. Francis Hospital and Medical Center

Hartford, Connecticut 06105

United States

Smilow Cancer Center

New Haven, Connecticut 06510

United States

Yale Cancer Center

New Haven, Connecticut 06520

United States

Smilow Cancer Hospital Care Center at Trumbull

Trumbull, Connecticut 06611

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Indiana University Health Melvin & Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

University of Kentucky Medical Center

Lexington, Kentucky 40536

United States

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

Boston, Massachusetts 02114-2621

United States

Boston Medical Center (BMC) - Cancer Care Center

Boston, Massachusetts 02118

United States

Henry Ford Health System

Detroit, Michigan 48202-2610

United States

University of Nebraska

Omaha, Nebraska 68198-5300

United States

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Cancer Center

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Cancer Center at Bergen

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York 11725

United States

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York 10604

United States

Northwell Health

Lake Success, New York 11042

United States

NYU Langone Health

New York, New York 10016

United States

Mount SInai Medical Center

New York, New York 10029

United States

Columbia University Medical Center

New York, New York 10032

United States

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

New York, New York 10065-7471

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Memorial Sloan Kettering Cancer Center at Nassau

Uniondale, New York 11553

United States

Duke Cancer Institute

Durham, North Carolina 27710-4000

United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio 45219

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Miriam Hospital

Providence, Rhode Island 02906

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

Antwerp University Hospital

Edegem, VAN 2650

Belgium

ULB Hôpital Erasme

Brussels, 1070

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

St Michael Hospital

Toronto, Ontario M5B 1W8

Canada

Princess Margaret Cancer Center

Toronto, Ontario M5G 2M9

Canada

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

Montreal, Quebec H2L 4M1

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037

France

Centre Leon Berard

Lyon, 69008

France

Institut Paoli Calmettes

Marseille, 13273

France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519

France

Gustave Roussy

Villejuif, 94805

France

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

Berlin, 13353

Germany

Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital

Bochum, 44791

Germany

Universitaetsklinikum Koeln

Cologne, 50937

Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Universitätsklinikum Essen

Essen, 45122

Germany

Krankenhaus Nordwest GmbH

Frankfurt, 60488

Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Ludwig-Maximilians-Universität München

München, 81377

Germany

Klinikum Bogenhausen

München, 81925

Germany

Universitaetsklinikum Tuebingen

Tübingen, 72076

Germany

Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale

Ulm, 89081

Germany

Uniklinikum Würzburg, Med. Klinik und Poliklinik II

Würzburg, 97080

Germany

Amsterdam UMC Location VUMC

Amsterdam, 1081 HV

Netherlands

UMC Radboud Nijmegen

Nijmegen, 6500 HB

Netherlands

Erasmus MC

Rotterdam, 3000 CA

Netherlands

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

Goyang-si, 410-769

South Korea

CHA Bundang Medical Center

Gyeonggi-do, 13496

South Korea

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

Seocho, 06591

South Korea

Seoul National University Bundang Hospital

Seongnam-si, 13620

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, 120-752

South Korea

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

Songpa-gu, 05505

South Korea

Institut Catala d?Oncologia Hospital Germans Trias i Pujol

Badalona, Barcelona 08916

Spain

Hospital Regional Universitario de Malaga

Málaga, Malaga 29010

Spain

Clinica Universitaria de Navarra (CUN)

Pamplona/iruña, Navarre 31008

Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias 33011

Spain

Hospital Universitario Vall d Hebron

Barcelona, 08035

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia

Madrid, 28027

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 De Octubre

Madrid, 28041

Spain

Centro Integral Oncológico Clara Campal Ensayos Clínicos START

Madrid, 28050

Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, 41 343

Sweden

Karolinska Universitetssjukhuset

Solna, 171 64

Sweden

Clatterbridge Cancer Centre Liverpool

Liverpool, LIV L7 8YA

United Kingdom

Belfast City Hospital

Belfast, BT9 7AB

United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH

United Kingdom

Addenbrookes Hospital

Cambridge, CB2 0QQ

United Kingdom

Barts Health NHS Trust

London, EC1A 7BE

United Kingdom

Guys Hospital

London, SE1 9RT

United Kingdom

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, W12 0HS

United Kingdom

University College London Cancer Institute

London, WC1E 6DD

United Kingdom