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

NCT05968326 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GO444792022-502404-73-00
• Study Type: interventional
• Target: 260
• Locations: 10 countries
• Sites: 89

Brief 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.

Conditions

Adenocarcinoma, Pancreatic Ductal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• DFS Rates at 12, 24, and 36 Months

  Months 12, 24, 36

• Overall Survival (OS)

  From randomization to death from any cause (up to approximately 6 years)

• OS Rates at 3 and 5 Years

  Years 3 and 5

• Percentage of Participants With Adverse Events (AEs)

  Up to approximately 6 years

Study Arms (2)

Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX

EXPERIMENTAL

Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

Drug: Autogene cevumeran; Drug: Atezolizumab; Drug: mFOLFIRINOX

Arm 2: mFOLFIRINOX

ACTIVE COMPARATOR

Participants will receive mFOLFIRINOX.

Drug: mFOLFIRINOX

Interventions

Autogene cevumeran DRUG

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

Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX

Atezolizumab DRUG

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

Also known as: Tecentriq

Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX

mFOLFIRINOX DRUG

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

Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX; Arm 2: mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• BioNTech SE: collaborator
• Genentech, Inc.: lead

Study Sites (89)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

USC Norris Cancer Center

Newport Beach, California, 92663, United States

RECRUITING

University of California, San Francisco (UCSF)

San Francisco, California, 94158-2350, United States

RECRUITING

University of California Los Angeles

Santa Monica, California, 90404, United States

RECRUITING

St. Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

RECRUITING

Smilow Cancer Center

New Haven, Connecticut, 06510, United States

WITHDRAWN

Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Smilow Cancer Hospital Care Center at Trumbull

Trumbull, Connecticut, 06611, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Indiana University Health Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

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

Boston, Massachusetts, 02114-2621, United States

RECRUITING

Boston Medical Center (BMC) - Cancer Care Center

Boston, Massachusetts, 02118, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202-2610, United States

RECRUITING

University of Nebraska

Omaha, Nebraska, 68198-5300, United States

RECRUITING

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Cancer Center at Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, 10604, United States

RECRUITING

Northwell Health

Lake Success, New York, 11042, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Mount SInai Medical Center

New York, New York, 10029, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

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

New York, New York, 10065-7471, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Cancer Center at Nassau

Uniondale, New York, 11553, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710-4000, United States

RECRUITING

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45219, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

RECRUITING

ULB Hôpital Erasme

Brussels, 1070, Belgium

RECRUITING

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

St Michael Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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

Montreal, Quebec, H2L 4M1, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13273, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

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

Berlin, 13353, Germany

RECRUITING

Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital

Bochum, 44791, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, 50937, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45122, Germany

RECRUITING

Krankenhaus Nordwest GmbH

Frankfurt, 60488, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Ludwig-Maximilians-Universität München

München, 81377, Germany

RECRUITING

Klinikum Bogenhausen

München, 81925, Germany

RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale

Ulm, 89081, Germany

RECRUITING

Uniklinikum Würzburg, Med. Klinik und Poliklinik II

Würzburg, 97080, Germany

RECRUITING

Amsterdam UMC Location VUMC

Amsterdam, 1081 HV, Netherlands

RECRUITING

UMC Radboud Nijmegen

Nijmegen, 6500 HB, Netherlands

RECRUITING

Erasmus MC

Rotterdam, 3000 CA, Netherlands

RECRUITING

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

Goyang-si, 410-769, South Korea

RECRUITING

CHA Bundang Medical Center

Gyeonggi-do, 13496, South Korea

RECRUITING

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

Seocho, 06591, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Severance Hospital - Yonsei Cancer Center

Seoul, 120-752, South Korea

RECRUITING

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

Songpa-gu, 05505, South Korea

RECRUITING

Institut Catala d?Oncologia Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, Malaga, 29010, Spain

RECRUITING

Clinica Universitaria de Navarra (CUN)

Pamplona/iruña, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitario Vall d Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia

Madrid, 28027, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Centro Integral Oncológico Clara Campal Ensayos Clínicos START

Madrid, 28050, Spain

RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, 41 343, Sweden

RECRUITING

Karolinska Universitetssjukhuset

Solna, 171 64, Sweden

RECRUITING

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

RECRUITING

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

RECRUITING

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

RECRUITING

Guys Hospital

London, SE1 9RT, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

University College London Cancer Institute

London, WC1E 6DD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GO44479 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); GB (8); US (32); ES (10); NL (3); KR (7); SE (2); BE (5); FR (5); DE (13)