NCT05968326Active, not recruitingPhase 2
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 18 Oct 2023
- Primary completion date
- 1 Jan 2031
- Lead sponsor
- Genentech, Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT05968326
- EU CT number
- 2022-502404-73-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 260
- From 18 Oct 2023 to the primary completion date, 1 Jan 2031
- 89 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
- 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).
Other illness
- 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
- Disorders of the colon or rectum, or postoperative complication leading to Grade \>/=2 diarrhea
- Active or history of autoimmune disease or immune deficiency
Other
- 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
- Pregnancy or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Active, not recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St Michael Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Muenchen Klinik gGmbH Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Institut De Cancerologie De Lorraine Coordinator of this site? Confirm its status | Vandouvre Les Nancy | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Clatterbridge Cancer Centre - Liverpool Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Imperial College Healthcare Nhs Trust - Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Cancer Institute Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guys Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital) Coordinator of this site? Confirm its status | Seocho | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Severance Hospital Yonsei Cancer Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC) Coordinator of this site? Confirm its status | Songpa-gu | South Korea | Unknown status |
| VUMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Radboud Universitair Medisch Centrum (Radboudumc) Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Sahlgrenska University Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Active, not recruiting |
| Memorial Sloan Kettering Cancer Center - Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Boston Medical Center (BMC) - Cancer Care Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Cancer Institute Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center - Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| St. Francis Hospital and Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Indiana University Health Melvin & Bren Simon Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| University of Kentucky Medical Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| USC Norris Cancer Center Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount SInai Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Nebraska Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Miriam Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| University of California, San Francisco (UCSF) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Smilow Cancer Hospital Care Center at Trumbull Coordinator of this site? Confirm its status | Trumbull | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.