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

Phase 2

Recruiting

• Conditions: Adenocarcinoma, Pancreatic Ductal
• Interventions: Drug: Autogene cevumeran; Drug: Atezolizumab; Drug: mFOLFIRINOX

• Registration Number: NCT05968326
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Study Start: 2023-10-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2029-12-27
• Study Completion: 2029-12-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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 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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX	Atezolizumab	Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX	mFOLFIRINOX	Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
Arm 2: mFOLFIRINOX	mFOLFIRINOX	Participants will receive mFOLFIRINOX.
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX	Autogene cevumeran	Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
DFS Rates at 12, 24, and 36 Months	Months 12, 24, 36

Trial Locations

Locations (68)

Severance Hospital - Yonsei Cancer Center; 🇰🇷 Seoul, Korea, Republic of

University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC); 🇰🇷 Songpa-gu, Korea, Republic of

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

USC Norris Cancer Center; 🇺🇸 Newport Beach, California, United States

University of California, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

St. Francis Hospital and Medical Center; 🇺🇸 Hartford, Connecticut, United States

Smilow Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Trumbull; 🇺🇸 Trumbull, Connecticut, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Indiana University Health Melvin & Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center (BMC) - Cancer Care Center; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

University of Nebraska; 🇺🇸 Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center at Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center at Westchester; 🇺🇸 Harrison, New York, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Mount SInai Medical Center; 🇺🇸 New York, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center at Nassau; 🇺🇸 Uniondale, New York, United States

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States

University of Cincinnati Cancer Institute; 🇺🇸 Cincinnati, Ohio, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

ULB Hôpital Erasme; 🇧🇪 Brussels, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

St Michael Hospital; 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Universite de Montreal (CHUM); 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-Les-Nancy, France

Gustave Roussy; 🇫🇷 Villejuif, France

Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB); 🇩🇪 Bochum, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Krankenhaus Nordwest GmbH; 🇩🇪 Frankfurt, Germany

Universitaetsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitaetsklinikum Tuebingen; 🇩🇪 Tuebingen, Germany

National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer; 🇰🇷 Goyang-si, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital); 🇰🇷 Seocho, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Institut Catala d?Oncologia Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Clinica Universitaria de Navarra (CUN); 🇪🇸 Pamplona/iruña, Navarra, Spain

Hospital Universitario Vall d Hebron; 🇪🇸 Barcelona, Spain

Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia; 🇪🇸 Madrid, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Centro Integral Oncológico Clara Campal Ensayos Clínicos START; 🇪🇸 Madrid, Spain

Sahlgrenska Universitetssjukhuset; 🇸🇪 Gothenburg, Sweden

Karolinska Universitetssjukhuset; 🇸🇪 Solna, Sweden

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

Hammersmith Hospital; 🇬🇧 London, United Kingdom

University College London Cancer Institute; 🇬🇧 London, United Kingdom