A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
Recruiting · NCT05968326 · Interventional (participants receive a specific treatment) · Lead sponsor: Genentech, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
60 locations listed across 14 US states.
- USC Norris Comprehensive Cancer Center - 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
- University of California Los Angeles - Santa Monica, 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 - Middletown, New Jersey, 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
- MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center at Nassau - Uniondale, New York, United States
- 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
- Amsterdam UMC Location VUMC - Amsterdam, Netherlands
- Hospital Universitario Vall d Hebron - Barcelona, Spain
- Belfast City Hospital - Belfast, United Kingdom
- Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Berlin, Germany
- University Hospitals Birmingham NHS Foundation Trust - Birmingham, United Kingdom
- Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital - Bochum, Germany
- ULB Hôpital Erasme - Brussels, Belgium
- Addenbrookes Hospital - Cambridge, United Kingdom
- Universitaetsklinikum Koeln - Cologne, Germany
- Universitätsklinikum Carl Gustav Carus Dresden - Dresden, Germany
- Universitätsklinikum Essen - Essen, Germany
- Krankenhaus Nordwest GmbH - Frankfurt, Germany
- AZ Maria Middelares - Ghent, Belgium
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Sahlgrenska Universitetssjukhuset - Gothenburg, Sweden
- National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer - Goyang-si, South Korea
- CHA Bundang Medical Center - Gyeonggi-do, South Korea
- Universitätsklinikum Hamburg-Eppendorf - Hamburg, Germany
- Universitaetsklinikum Heidelberg - Heidelberg, Germany
- UZ Leuven - Leuven, Belgium
- Centre Hospitalier Régional Universitaire de Lille - Lille, France
- Barts Health NHS Trust - London, United Kingdom
- Guys Hospital - London, United Kingdom
- Imperial College Healthcare NHS Trust - Hammersmith Hospital - London, United Kingdom
- University College London Cancer Institute - London, United Kingdom
- Centre Leon Berard - Lyon, France
- Hospital General Universitario Gregorio Marañon - Madrid, Spain
- Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia - Madrid, Spain
Showing 60 of 89 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →