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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.
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

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopital Erasme
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AnderlechtBelgiumActive, not recruiting
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Az Maria Middelares Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Jewish General Hospital
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MontrealCanadaUnknown status
Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
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MontrealCanadaUnknown status
Princess Margaret Cancer Center
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TorontoCanadaUnknown status
St Michael Hospital
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TorontoCanadaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Technische Universität Dresden
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Muenchen Klinik gGmbH
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MunichGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Clinica Universidad de Navarra
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Institut De Cancerologie De Lorraine
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Vandouvre Les NancyFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Belfast City Hospital
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BelfastUnited KingdomUnknown status
University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Addenbrookes Hospital
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CambridgeUnited KingdomUnknown status
Clatterbridge Cancer Centre - Liverpool
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LiverpoolUnited KingdomUnknown status
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
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LondonUnited KingdomUnknown status
University College London Cancer Institute
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LondonUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Guys Hospital
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LondonUnited KingdomUnknown status
National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer
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Goyang-siSouth KoreaUnknown status
CHA Bundang Medical Center
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Gyeonggi-doSouth KoreaUnknown status
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
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SeochoSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Severance Hospital Yonsei Cancer Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
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Songpa-guSouth KoreaUnknown status
VUMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenActive, not recruiting
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
Memorial Sloan Kettering Cancer Center - Basking Ridge
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Basking RidgeUnited StatesUnknown status
Boston Medical Center (BMC) - Cancer Care Center
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BostonUnited StatesUnknown status
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
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BostonUnited StatesUnknown status
Northwestern Memorial Hospital
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ChicagoUnited StatesUnknown status
University of Cincinnati Cancer Institute
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CincinnatiUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center - Commack
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CommackUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Duke Cancer Institute
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DurhamUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at Westchester
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HarrisonUnited StatesUnknown status
St. Francis Hospital and Medical Center
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HartfordUnited StatesUnknown status
Indiana University Health Melvin & Bren Simon Cancer Center
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IndianapolisUnited StatesUnknown status
Northwell Health
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Lake SuccessUnited StatesUnknown status
University of Kentucky Medical Center
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LexingtonUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center
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MiddletownUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at Bergen
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MontvaleUnited StatesUnknown status
Yale Cancer Center
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New HavenUnited StatesUnknown status
USC Norris Cancer Center
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Newport BeachUnited StatesUnknown status
MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH
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New YorkUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Mount SInai Medical Center
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
University of Nebraska
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OmahaUnited StatesUnknown status
Miriam Hospital
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ProvidenceUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
University of California, San Francisco (UCSF)
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San FranciscoUnited StatesUnknown status
University of California, Los Angeles
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Santa MonicaUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
Smilow Cancer Hospital Care Center at Trumbull
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TrumbullUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at Nassau
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UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.