Clinical trial • Phase III • Oncology
DURVALUMAB for Locoregional hepatocellular carcinoma
Phase III trial of DURVALUMAB for Locoregional hepatocellular carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Locoregional hepatocellular carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 15-03-2024
- First CTIS Authorization Date
- 19-04-2024
Trial design
Randomised, open-label, three arms: arm a: tace + tremelimumab + durvalumab + lenvatinib, then q4w durvalumab + lenvatinib; arm b: tace + tremelimumab + durvalumab, then q4w durvalumab; arm c (comparator): tace alone-controlled Phase III trial in Belgium, Italy, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Three arms: Arm A: TACE + Tremelimumab + Durvalumab + Lenvatinib, then Q4W Durvalumab + Lenvatinib; Arm B: TACE + Tremelimumab + Durvalumab, then Q4W Durvalumab; Arm C (comparator): TACE alone
- Target Sample Size
- 594
Eligibility
Recruits 594 Vulnerable population selected. The trial documentation includes specific informed consent / subject information forms for adult participants and separate documents for pregnant subjects and partners (e.g. 'L1_SIS and ICF Pregnant subject and partner' documents). Consent is obtained from adult participants; no paediatric assent documents are provided in the available materials..
- Vulnerable Population
- Vulnerable population selected. The trial documentation includes specific informed consent / subject information forms for adult participants and separate documents for pregnant subjects and partners (e.g. 'L1_SIS and ICF Pregnant subject and partner' documents). Consent is obtained from adult participants; no paediatric assent documents are provided in the available materials.
Inclusion criteria
- {"criterion_text":"- No evidence of extrahepatic disease"}
- {"criterion_text":"- Disease not amenable to curative surgery or transplantation or curative ablation"}
- {"criterion_text":"- Disease must be amenable to TACE"}
- {"criterion_text":"- Child-Pugh score class A and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
- {"criterion_text":"- Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria"}
- {"criterion_text":"- Adequate organ and marrow function"}
Exclusion criteria
- {"criterion_text":"- History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia"}
- {"criterion_text":"- History of encephalopathy within past 12 months"}
- {"criterion_text":"- Uncontrolled arterial hypertension"}
- {"criterion_text":"- Co-infection with HBV and HDV"}
- {"criterion_text":"- Major portal vein thrombosis visible on baseline imaging"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR","definition_or_measurement_approach":"PFS measured per RECIST 1.1 and assessed by blinded independent central review (BICR)"}
Secondary endpoints
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 594
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent obtained from adult participants using subject information sheets (SIS) and informed consent forms (ICF). Multiple language ICF/SIS documents are provided (examples include English, French, Dutch, Italian, German and Portuguese versions across sites). Specific ICFs/addenda are provided for pregnant participants and for partners of pregnant participants. No paediatric assent documentation is provided in the available materials.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 131
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 26-04-2024
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Maag-, Darm- en Leverziekten
- Principal Investigator Name
- Hans Van Vlierberghe
- Principal Investigator Email
- hans.vanvlierberghe@uzgent.be
- Contact Person Name
- Hans Van Vlierberghe
- Contact Person Email
- hans.vanvlierberghe@uzgent.be
- Site Name
- Hopital Erasme
- Department Name
- Gastroentérologie médicale
- Principal Investigator Name
- Anne Demols
- Principal Investigator Email
- Anne.Demols@erasme.ulb.ac.be
- Contact Person Name
- Anne Demols
- Contact Person Email
- Anne.Demols@erasme.ulb.ac.be
Italy
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 13-05-2024
- Processing Time Days
- 35
- Number Of Sites
- 7
- Number Of Participants
- 27
Sites
- Site Name
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Marianna Silletta
- Principal Investigator Email
- m.silletta@policlinicocampus.it
- Contact Person Name
- Marianna Silletta
- Contact Person Email
- m.silletta@policlinicocampus.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Andrea Casadei Gardini
- Principal Investigator Email
- casadeigardini.andrea@hsr.it
- Contact Person Name
- Andrea Casadei Gardini
- Contact Person Email
- casadeigardini.andrea@hsr.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Oncologia
- Principal Investigator Name
- Tiziana Pressiani
- Principal Investigator Email
- tiziana.pressiani@cancercenter.humanitas.it
- Contact Person Name
- Tiziana Pressiani
- Contact Person Email
- tiziana.pressiani@cancercenter.humanitas.it
- Site Name
- Azienda USL Toscana Sud Est
- Department Name
- U.O. Oncologia Medica
- Principal Investigator Name
- Michele Sisani
- Principal Investigator Email
- michele.sisani@uslsudest.toscana.it
- Contact Person Name
- Michele Sisani
- Contact Person Email
- michele.sisani@uslsudest.toscana.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Chirurgia Apparato Digerente (epato-gastro-pancreatico) e Trapianto di Fegato
- Principal Investigator Name
- Vincenzo Mazzaferro
- Principal Investigator Email
- vincenzo.mazzaferro@istitutotumori.mi.it
- Contact Person Name
- Vincenzo Mazzaferro
- Contact Person Email
- vincenzo.mazzaferro@istitutotumori.mi.it
- Site Name
- Careggi University Hospital
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Lorenzo Antonuzzo
- Principal Investigator Email
- lorenzo.antonuzzo@gmail.com
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- lorenzo.antonuzzo@gmail.com
- Site Name
- Pia Fondazione Di Culto E Religione Card G Panico
- Department Name
- Dipartimento Oncologico
- Principal Investigator Name
- Emiliano Tamburini
- Principal Investigator Email
- emilianotamburini@icloud.com
- Contact Person Name
- Emiliano Tamburini
- Contact Person Email
- emilianotamburini@icloud.com
France
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 26-04-2024
- Processing Time Days
- 18
- Number Of Sites
- 10
- Number Of Participants
- 28
Sites
- Site Name
- University Hospitals Pitie Salpetriere Charles Foix
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- Manon Allaire
- Principal Investigator Email
- manon.allaire@aphp.fr
- Contact Person Name
- Manon Allaire
- Contact Person Email
- manon.allaire@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Hépato Gastro-entérologie et Oncologie Digestive
- Principal Investigator Name
- Anne-Claire Frin
- Principal Investigator Email
- frin.ac@chu-nice.fr
- Contact Person Name
- Anne-Claire Frin
- Contact Person Email
- frin.ac@chu-nice.fr
- Site Name
- Hopital Beaujon
- Department Name
- Oncologie Medicale et Digestive
- Principal Investigator Name
- Mohamed Bouattour
- Principal Investigator Email
- mohamed.bouattour@aphp.fr
- Contact Person Name
- Mohamed Bouattour
- Contact Person Email
- mohamed.bouattour@aphp.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Hepathology
- Principal Investigator Name
- Frédéric Oberti
- Principal Investigator Email
- froberti@chu-angers.fr
- Contact Person Name
- Frédéric Oberti
- Contact Person Email
- froberti@chu-angers.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Pôle Hépato-Digestif
- Principal Investigator Name
- Simona Tripon
- Principal Investigator Email
- simona.tripon@chru-strasbourg.fr
- Contact Person Name
- Simona Tripon
- Contact Person Email
- simona.tripon@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hépatologie
- Principal Investigator Name
- Hélène Regnault
- Principal Investigator Email
- helene.regnault@aphp.fr
- Contact Person Name
- Hélène Regnault
- Contact Person Email
- helene.regnault@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hépato-Gastroenterologie
- Principal Investigator Name
- Jean-Marie Peron
- Principal Investigator Email
- peron.jm@chu-toulouse.fr
- Contact Person Name
- Jean-Marie Peron
- Contact Person Email
- peron.jm@chu-toulouse.fr
- Site Name
- CHRU De Nancy
- Department Name
- Hépato-Gastroenterologie
- Principal Investigator Name
- Jean-Pierre Bronowicki
- Principal Investigator Email
- jp.bronowicki@chru-nancy.fr
- Contact Person Name
- Jean-Pierre Bronowicki
- Contact Person Email
- jp.bronowicki@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hépato-Gastroenterologie
- Principal Investigator Name
- Yann Touchefeu
- Principal Investigator Email
- yann.touchefeu@chu-nantes.fr
- Contact Person Name
- Yann Touchefeu
- Contact Person Email
- yann.touchefeu@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service Oncologie Medicale
- Principal Investigator Name
- Eric Assenat
- Principal Investigator Email
- e-assenat@chu-montpellier.fr
- Contact Person Name
- Eric Assenat
- Contact Person Email
- e-assenat@chu-montpellier.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 19-04-2024
- Processing Time Days
- 11
- Number Of Sites
- 6
- Number Of Participants
- 19
Sites
- Site Name
- Vall D'hebron Institut De Recerca
- Department Name
- Hepathology
- Principal Investigator Name
- Beatriz Mínguez Rosique
- Principal Investigator Email
- beatriz.minguez@vallhebron.cat
- Contact Person Name
- Beatriz Mínguez Rosique
- Contact Person Email
- beatriz.minguez@vallhebron.cat
- Site Name
- Hospital Universitario Donostia
- Department Name
- Oncology
- Principal Investigator Name
- Adelaida La Casta Muñoa
- Principal Investigator Email
- ADELAIDA.LACASTAMUNOA@osakidetza.eus
- Contact Person Name
- Adelaida La Casta Muñoa
- Contact Person Email
- ADELAIDA.LACASTAMUNOA@osakidetza.eus
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hepathology
- Principal Investigator Name
- María Elisa Reig Monzón
- Principal Investigator Email
- MREIG1@clinic.cat
- Contact Person Name
- María Elisa Reig Monzón
- Contact Person Email
- MREIG1@clinic.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hepathology
- Principal Investigator Name
- José Luis Lledó Navarro
- Principal Investigator Email
- jllledo63@yahoo.es
- Contact Person Name
- José Luis Lledó Navarro
- Contact Person Email
- jllledo63@yahoo.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hepathology
- Principal Investigator Name
- Ana María Matilla Peña
- Principal Investigator Email
- estudiosamatilla@gmail.com
- Contact Person Name
- Ana María Matilla Peña
- Contact Person Email
- estudiosamatilla@gmail.com
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Hepathology
- Principal Investigator Name
- José Luis Montero Álvarez
- Principal Investigator Email
- jluis.montero.sspa@juntadeandalucia.es
- Contact Person Name
- José Luis Montero Álvarez
- Contact Person Email
- jluis.montero.sspa@juntadeandalucia.es
Germany
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 14
- Number Of Sites
- 13
- Number Of Participants
- 25
Sites
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Thomas Ettrich
- Principal Investigator Email
- thomas.ettrich@uniklinik-ulm.de
- Contact Person Name
- Thomas Ettrich
- Contact Person Email
- thomas.ettrich@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Klinik und Poliklinik für Onkologie, Gastroenterologie; Hepatologie, Pneumologie und Infektiologie
- Principal Investigator Name
- Florian van Bömmel
- Principal Investigator Email
- florian.vanboemmel@medizin.uni-leipzig.de
- Contact Person Name
- Florian van Bömmel
- Contact Person Email
- florian.vanboemmel@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Gastroenterologie, Hepatologie und Infektiologie; Bereich: GI Onkologie
- Principal Investigator Name
- Christoph Roderburg
- Principal Investigator Email
- Christoph.Roderburg@med.uni-duesseldorf.de
- Contact Person Name
- Christoph Roderburg
- Contact Person Email
- Christoph.Roderburg@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Rainer Günther
- Principal Investigator Email
- Rainer.Guenther@uksh.de
- Contact Person Name
- Rainer Günther
- Contact Person Email
- Rainer.Guenther@uksh.de
- Site Name
- National Center For Tumor Diseases (NCT) Heidelberg
- Department Name
- Medizinische Klinik; Innere Medizin IV: Gastroenterologie
- Principal Investigator Name
- Michael Dill
- Principal Investigator Email
- michael.dill@med.uni-heidelberg.de
- Contact Person Name
- Michael Dill
- Contact Person Email
- michael.dill@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Medizinische Klinik 1
- Principal Investigator Name
- Jörg Trojan
- Principal Investigator Email
- trojan@em.uni-frankfurt.de
- Contact Person Name
- Jörg Trojan
- Contact Person Email
- trojan@em.uni-frankfurt.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Medizinische Klinik und Poliklinik 1
- Principal Investigator Name
- Maria A. Gonzalez-Carmona
- Principal Investigator Email
- maria.gonzalez-carmona@ukbonn.de
- Contact Person Name
- Maria A. Gonzalez-Carmona
- Contact Person Email
- maria.gonzalez-carmona@ukbonn.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Abteilung für Hämatologie, Onkologie und Palliativmedizin
- Principal Investigator Name
- Axel Stang
- Principal Investigator Email
- a.stang@asklepios.com
- Contact Person Name
- Axel Stang
- Contact Person Email
- a.stang@asklepios.com
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Klinik für Innere Medizin III
- Principal Investigator Name
- Ilja Kubisch
- Principal Investigator Email
- i.kubisch@skc.de
- Contact Person Name
- Ilja Kubisch
- Contact Person Email
- i.kubisch@skc.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Gastroenterologie, Hepatologie, Endokrinologie
- Principal Investigator Name
- Thomas Wirth
- Principal Investigator Email
- wirth.thomas@mh-hannover.de
- Contact Person Name
- Thomas Wirth
- Contact Person Email
- wirth.thomas@mh-hannover.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Gastroenterologie und gastrointestinale Onkologie
- Principal Investigator Name
- Alexander König
- Principal Investigator Email
- alexander.koenig@med.uni-goettingen.de
- Contact Person Name
- Alexander König
- Contact Person Email
- alexander.koenig@med.uni-goettingen.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Anke Kröcher
- Principal Investigator Email
- anke.kroecher@uniklinikum-dresden.de
- Contact Person Name
- Anke Kröcher
- Contact Person Email
- anke.kroecher@uniklinikum-dresden.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Zentrum für Innere Medizin; Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
- Principal Investigator Name
- Marino Venerito
- Principal Investigator Email
- m.venerito@med.ovgu.de
- Contact Person Name
- Marino Venerito
- Contact Person Email
- m.venerito@med.ovgu.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Gastrenterologia
- Principal Investigator Name
- Sofia Carvalhana
- Principal Investigator Email
- sofiacarvalhana@msn.com
- Contact Person Name
- Sofia Carvalhana
- Contact Person Email
- sofiacarvalhana@msn.com
- Site Name
- Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
- Department Name
- Hepatologia
- Principal Investigator Name
- José Presa Ramos
- Principal Investigator Email
- jpresa@chtmad.min-saude.pt
- Contact Person Name
- José Presa Ramos
- Contact Person Email
- jpresa@chtmad.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- IMFINZI 50 mg/mL concentrate for solution for infusion.
- Active Substance
- DURVALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/18/1322/001)
- Investigational Product Name
- IMJUDO 20 mg/ml concentrate for solution for infusion.
- Active Substance
- TREMELIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/22/1713/001)
- Investigational Product Name
- LENVIMA 4 mg hard capsules
- Active Substance
- LENVATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/15/1002/001)
- Combination Treatment
- Yes
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