A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
- Conditions
- Adenocarcinoma, Pancreatic Ductal
- Interventions
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
- 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.
- 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