Clinical trial • Phase III • Oncology
DURVALUMAB for Hepatocellular carcinoma (advanced)
Phase III trial of DURVALUMAB for Hepatocellular carcinoma (advanced).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hepatocellular carcinoma (advanced)
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 18-06-2024
- First CTIS Authorization Date
- 12-07-2024
Trial design
Randomised, open-label, arm d: sorafenib 400 mg bid therapy; other arms: arm a durvalumab 1500 mg monotherapy; arm b durvalumab 1500 mg + tremelimumab 75 mg ×4 doses; arm c durvalumab 1500 mg + tremelimumab 300 mg ×1 dose.-controlled Phase III trial across 26 sites in Italy, Spain, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arm D: Sorafenib 400 mg BID therapy; Other arms: Arm A Durvalumab 1500 mg monotherapy; Arm B Durvalumab 1500 mg + Tremelimumab 75 mg ×4 doses; Arm C Durvalumab 1500 mg + Tremelimumab 300 mg ×1 dose.
- Biomarker Stratified
- True, PD-L1 expression (strata not specified)
- Target Sample Size
- 1302
Eligibility
Recruits 1302 adults.
Inclusion criteria
- {"criterion_text":"- HCC based on histopathological confirmation"}
- {"criterion_text":"- No prior systemic therapy for HCC"}
- {"criterion_text":"- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C"}
- {"criterion_text":"- Child-Pugh Score class A"}
- {"criterion_text":"- ECOG performance status of 0 or 1 at enrollment"}
Exclusion criteria
- {"criterion_text":"- Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy"}
- {"criterion_text":"-\tClinical meaningful ascites"}
- {"criterion_text":"-\tMain portal vein thrombosis"}
- {"criterion_text":"-\tActive or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months"}
- {"criterion_text":"-\tHBV and HVC coinfection, or HBV and Hep D coinfection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival (OS) is defined as the time from the date of randomization until death due to any cause.","definition_or_measurement_approach":"Time from the date of randomization until death due to any cause."}
Secondary endpoints
- {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to progression (TTP)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Objective response rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Disease control rate (DCR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":""}
Other endpoints
- {"endpoint_text":"- To assess the efficacy of durvalumab monotherapy compared with sorafenib","definition_or_measurement_approach":""}
- {"endpoint_text":"- To assess the safety and tolerability profile across all treatment arms","definition_or_measurement_approach":""}
- {"endpoint_text":"- To assess the efficacy of durvalumab monotheraphy and durvalumab plus tremelimumab combination theraphy compared with sorafenib by PD-L1 expression","definition_or_measurement_approach":""}
- {"endpoint_text":"- To assess disease-related symptoms, impacts, and health-related quality of life (HRQoL) in durvalumab monotheraphy and durvalumab plus tremelimimab combination therapy compared with sorafenib","definition_or_measurement_approach":""}
- {"endpoint_text":"- To evaluate the population PK and pharmacodynamics of durvalumab monotheraphy and durvalumab plus tremelimumab combination therapy","definition_or_measurement_approach":""}
- {"endpoint_text":"- To investigate the immunogenicity of durvalumab monotheraphy and durvalumab plus tremelimumab combination therapy","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 1302
- Recruitment Window Months
- 6
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 302
Italy
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 29-08-2025
- Processing Time Days
- 427
- Number Of Sites
- 5
- Number Of Participants
- 77
Sites
- Site Name
- Azienda Ospedaliera “G. Rummo”
- Department Name
- U.O.C. ONCOLOGIA MEDICA
- Principal Investigator Name
- Domenico Germano
- Principal Investigator Email
- domgerm@libero.it
- Contact Person Name
- Domenico Germano
- Contact Person Email
- domgerm@libero.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U. O. ONCOLOGIA MEDICA
- Principal Investigator Name
- Gianluca Masi
- Principal Investigator Email
- gianluca.masi@unipi.it
- Contact Person Name
- Gianluca Masi
- Contact Person Email
- gianluca.masi@unipi.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- U.O.DI ONCOLOGIA MEDICA ED EMATOLOGIA
- Principal Investigator Name
- Lorenza Rimassa
- Principal Investigator Email
- lorenza.rimassa@cancercenter.humanitas.it
- Contact Person Name
- Lorenza Rimassa
- Contact Person Email
- lorenza.rimassa@cancercenter.humanitas.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dipartimento di Medicina e chirurgia traslazionale
- Principal Investigator Name
- Antonio Gasbarrini
- Principal Investigator Email
- antonio.gasbarrini@unicatt.it
- Contact Person Name
- Antonio Gasbarrini
- Contact Person Email
- antonio.gasbarrini@unicatt.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- U.O. Oncologia Medica
- Principal Investigator Name
- Monica Ronzoni
- Principal Investigator Email
- ronzoni.monica@hsr.it
- Contact Person Name
- Monica Ronzoni
- Contact Person Email
- ronzoni.monica@hsr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 04-08-2025
- Processing Time Days
- 402
- Number Of Sites
- 4
- Number Of Participants
- 42
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Unidad de Hepatología
- Principal Investigator Name
- Jorge Adeva Alfonso
- Principal Investigator Email
- jorge.adeva@salud.madrid.org
- Contact Person Name
- Jorge Adeva Alfonso
- Contact Person Email
- jorge.adeva@salud.madrid.org
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Unidad de Hepatología
- Principal Investigator Name
- Maria Varela Calvo
- Principal Investigator Email
- maria.varela.calvo@gmail.com
- Contact Person Name
- Maria Varela Calvo
- Contact Person Email
- maria.varela.calvo@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Unidad de Hepatología
- Principal Investigator Name
- Bruno Sangro
- Principal Investigator Email
- bsangro@unav.es
- Contact Person Name
- Bruno Sangro
- Contact Person Email
- bsangro@unav.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Unidad de Hepatología
- Principal Investigator Name
- Maria Elisa Reig Monzón
- Principal Investigator Email
- MREIG1@clinic.cat
- Contact Person Name
- Maria Elisa Reig Monzón
- Contact Person Email
- MREIG1@clinic.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 647
- Number Of Sites
- 6
- Number Of Participants
- 69
Sites
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Gastroenterologie, Hepatologie und 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
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik 2 Poliklinik Gastroenterologie
- Principal Investigator Name
- Alexander Philipp
- Principal Investigator Email
- Alexander.Philipp@med.uni-muenchen.de
- Contact Person Name
- Alexander Philipp
- Contact Person Email
- Alexander.Philipp@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Gastroenterologie und Hepatologie Medizinisches Zentrum
- Principal Investigator Name
- Katharina Willuweit
- Principal Investigator Email
- katharina.willuweit@uk-essen.de
- Contact Person Name
- Katharina Willuweit
- Contact Person Email
- katharina.willuweit@uk-essen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik für Gastroenterologie und Hepatologie
- Principal Investigator Name
- Dirk Waldschmidt
- Principal Investigator Email
- dirk-thomas.waldschmidt@uk-koeln.de
- Contact Person Name
- Dirk Waldschmidt
- Contact Person Email
- dirk-thomas.waldschmidt@uk-koeln.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik für Gastroenterologie Medizinische Klinik III
- Principal Investigator Name
- Marie-Luise Berres
- Principal Investigator Email
- mberres@ukaachen.de
- Contact Person Name
- Marie-Luise Berres
- Contact Person Email
- mberres@ukaachen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Abteilung Innere Medizin I Hepatologie, Gastroenterologie, Infektiologie
- Principal Investigator Name
- Michael Bitzer
- Principal Investigator Email
- michael.bitzer@med.uni-tuebingen.de
- Contact Person Name
- Michael Bitzer
- Contact Person Email
- michael.bitzer@med.uni-tuebingen.de
France
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 311
- Number Of Sites
- 11
- Number Of Participants
- 114
Sites
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jean-Marc PHELIP
- Principal Investigator Email
- j.marc.phelip@chu-st-etienne.fr
- Contact Person Name
- Jean-Marc PHELIP
- Contact Person Email
- j.marc.phelip@chu-st-etienne.fr
- Site Name
- CHU Hôtel Dieu
- Department Name
- Hepato-gastroenterology
- 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
- Institut Paoli Calmettes
- Department Name
- Medical oncology
- Principal Investigator Name
- Simon Launay
- Principal Investigator Email
- launays@ipc.unicancer.fr
- Contact Person Name
- Simon Launay
- Contact Person Email
- launays@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Medical oncology
- Principal Investigator Name
- Frédéric DI FIORE
- Principal Investigator Email
- Frederic.Di-Fiore@chu-rouen.fr
- Contact Person Name
- Frédéric DI FIORE
- Contact Person Email
- Frederic.Di-Fiore@chu-rouen.fr
- Site Name
- Hopital Beaujon
- Department Name
- Service d'Oncologie 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
- C.H.U. de Montpellier - Hopital Saint Eloi
- Department Name
- Medical oncology
- Principal Investigator Name
- Eric ASSENAT
- Principal Investigator Email
- celine-girard@chu-montpellier.fr
- Contact Person Name
- Eric ASSENAT
- Contact Person Email
- celine-girard@chu-montpellier.fr
- Site Name
- CHU Toulouse Rangueil
- Department Name
- Digestive and Gynecological Medical Oncology
- 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
- Hepato-gastroenterology
- 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 Nice
- Department Name
- Hepato-gastroenterology
- 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
- CHU de Poitiers
- Department Name
- Hepato-gastroenterology
- Principal Investigator Name
- David TOUGERON
- Principal Investigator Email
- david.tougeron@chu-poitiers.fr
- Contact Person Name
- David TOUGERON
- Contact Person Email
- david.tougeron@chu-poitiers.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical oncology
- Principal Investigator Name
- Valérie BOIGE
- Principal Investigator Email
- valerie.boige@gustaveroussy.fr
- Contact Person Name
- Valérie BOIGE
- Contact Person Email
- valerie.boige@gustaveroussy.fr
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/1/18/1322/001)
- Starting Dose
- 1500 mg
- Dose Levels
- 1500 mg
- Maximum Dose
- 1500 mg
- 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/1/22/1713/002)
- Starting Dose
- 75 mg (one regimen) and 300 mg (alternative single-dose regimen)
- Dose Levels
- 75 mg ×4 doses; 300 mg ×1 dose
- Maximum Dose
- 300 mg
- Investigational Product Name
- Nexavar 200 mg film-coated tablets
- Active Substance
- SORAFENIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (EU/1/06/342/001)
- Starting Dose
- 400 mg BID (as described for Arm D)
- Dose Levels
- 400 mg BID
- Frequency
- BID
- Maximum Dose
- 400 mg BID
- Investigational Product Name
- Mycophenolate Mofetil 500 mg film-coated tablets
- Active Substance
- MYCOPHENOLATE MOFETIL
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (PL 20117/0065)
- Investigational Product Name
- Inflectra 100 mg powder for concentrate for solution for infusion
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (EU/1/13/854/002)
- Combination Treatment
- Yes
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