Clinical trial • Phase III • Oncology

Durvalumab for Hepatocellular carcinoma

Phase III trial of Durvalumab for Hepatocellular carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Hepatocellular carcinoma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
15-01-2024
First CTIS Authorization Date
19-03-2024

Trial design

Randomised, arm a: durvalumab + bevacizumab q3w for 12 months; arm b: durvalumab + bevacizumab placebo q3w for 12 months; arm c: durvalumab placebo + bevacizumab placebo q3w for 12 months-controlled Phase III trial in Austria, France, Germany and others.

Randomised
Yes
Comparator
Arm A: Durvalumab + bevacizumab Q3W for 12 months; Arm B: Durvalumab + bevacizumab placebo Q3W for 12 months; Arm C: Durvalumab placebo + bevacizumab placebo Q3W for 12 months
Target Sample Size
803
Trial Duration For Participant
365

Eligibility

Recruits 803 Vulnerable population selected (isVulnerablePopulationSelected = true). The record lists subject information and informed consent form documents, but the CTIS data does not provide details in the eligibility text about consent/assent procedures for vulnerable participants or minors..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). The record lists subject information and informed consent form documents, but the CTIS data does not provide details in the eligibility text about consent/assent procedures for vulnerable participants or minors.

Inclusion criteria

  • {"criterion_text":"-1.Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation) 2.Imaging to confirm disease-free status within 28 days prior to randomization 3.ECOG 0-1 at enrolment 4.Child-Pugh score of 5 or 6 5.Patients with HBV infection must receive antiviral therapy at least after enrollment per institutional practice to ensure adequate viral suppression prior to randomization. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. 6.Patients with HCV infection must be managed per local institutional practice for the study. 7.Adequate organ and marrow function, as defined by the CSP"}

Exclusion criteria

  • {"criterion_text":"-1.Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC 2.Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging. 3.History of hepatic encephalopathy within 12 months prior to randomization 4.Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging 5.Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded. 6.Active co-infection with HBV and HDV. 7.Receipt of prior systemic anticancer therapy for HCC 8.Those on a waiting list for liver transplantation"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Recurrence-free survival (RFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-Overall survival (OS)\n-Time to recurrence (TTR)\n-RFS at 24 months (RFS24)\n-RFS at 36 months (RFS36)\n-Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
803
Recruitment Window Months
40
Consent Approach
Informed consent documents for adult participants are listed in the CTIS documents (e.g. 'L1_SIS and ICF Adult Subject Part II German redacted', 'L1_SIS and ICF Future Research Part II German', 'L1_SIS and Adult participant Redacted', 'L1_SIS and Adult Subject Addendum redacted', 'L1_SIS and ICF Pregnant Partners clean'). The CTIS record does not provide the full text of consent/assent procedures or age-specific consent handling; no details on assent for minors are provided.

Geography

Total Number Of Sites
33
Total Number Of Participants
94

Austria

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
19-03-2024
Processing Time Days
28
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
2. Medical Department
Contact Person Name
Andreas Maieron
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal I: Medical Oncology and Hematology Study coordination
Contact Person Name
Franz Oliver Romeder
Contact Person Email
zfks.bhs@ordensklinikum.at

France

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
19-03-2024
Processing Time Days
26
Number Of Sites
11
Number Of Participants
43

Sites

Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service d'Hépato-gastro et oncologie digestive
Contact Person Name
Sylvain MANFREDI
Contact Person Email
sylvain.manfredi@chu-dijon.fr
Site Name
Besancon University Hospital Center
Department Name
Service Hepatologie
Contact Person Name
Carine RICHOU
Contact Person Email
crichou@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service d’Hépato-Gastroentérologie
Contact Person Name
Eric NGUYEN-KHAC
Contact Person Email
nguyen-khac.eric@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service d'Hepato-Gastroentérologie
Contact Person Name
Frédéric OBERTI
Contact Person Email
FrOberti@chu-angers.fr
Site Name
Hopital Beaujon
Department Name
Service d'Oncologie Digestive
Contact Person Name
Mohamed BOUATTOUR
Contact Person Email
mohamed.bouattour@aphp.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hépato-gastroentérologie et Cancérologie Digestive
Contact Person Name
Thierry LECOMTE
Contact Person Email
thierry.lecomte@univ-tours.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pôle de Référence Hépato Gastro-entérologie et Oncologie Digestive
Contact Person Name
Anne Claire FRIN
Contact Person Email
frin.ac@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'hépatogastro-entérologie
Contact Person Name
Yann TOUCHEFEU
Contact Person Email
yann.touchefeu@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hépatologie
Contact Person Name
Jean-Marie PERON
Contact Person Email
peron.jm@chu-toulouse.fr
Site Name
Hopital Saint Antoine
Department Name
Service d'hépato-gastro-entérologie
Contact Person Name
Marie LEQUOY
Contact Person Email
marie.lequoy@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'Hépato-gastro-entérologie et oncologie digestive
Contact Person Name
Jean-Frédéric BLANC

Germany

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
29
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik m. S. Hepatologie und Gastroenterologie
Contact Person Name
Raphael Mohr
Contact Person Email
raphael.mohr@charite.de
Site Name
Medical Center - University Of Freiburg
Department Name
Department Chirurgie Klinik für Allgemein- und Viszeralchirurgie
Contact Person Name
Philipp Holzner
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Gastroenterologie /Gastroenterologische Onkologie
Contact Person Name
Ilja Kubisch
Contact Person Email
i.kubisch@skc.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik II
Contact Person Name
Alexander Philipp
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin I Hepatologie, Gastroenterologie, Infektologie
Contact Person Name
Michael Bitzer
Site Name
University Hospital Cologne AöR
Department Name
Klinik für Gastroenterologie und Hepatologie
Contact Person Name
Dirk Thomas Waldschmidt
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik I Onkologische Gastroenterologie
Contact Person Name
Maria A. Gonzalez-Carmona
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Medizinische Klinik I Studienzentrale MKI
Contact Person Name
Jens Marquardt
Contact Person Email
jens.marquardt@uksh.de

Italy

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
26
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Universita Degli Studi Di Verona
Department Name
Oncology
Contact Person Name
Michele Milella
Contact Person Email
michele.milella@aovr.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Department of Digestive System
Contact Person Name
Fabio Piscaglia
Contact Person Email
fabio.piscaglia@unibo.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncology
Contact Person Name
Emiliano Tamburini
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncology
Contact Person Name
Andrea Casadei Gardini
Contact Person Email
gianni.luca@hsr.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia Falck
Contact Person Name
Salvatore Siena
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Basso
Contact Person Name
Michele Basso
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
abdominal Oncology
Contact Person Name
Antonio Avallone
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncology
Contact Person Name
Erika Martinelli

Poland

Earliest CTIS Part Ii Submission Date
14-02-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
40
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii i Oddział Kliniczny Radioterapii
Contact Person Name
Bogdan Zurawski
Contact Person Email
bzur1@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Renata Zaucha
Contact Person Email
rzaucha@gumed.edu.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Contact Person Name
Radoslaw Osmanski
Contact Person Email
radoslaw.osmanski@wco.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjanwyrwicz@gmail.com

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 USE
Route
INTRAVENOUS
Authorisation Status
EU/1/18/1322/002
Frequency
Q3W
Investigational Product Name
BEVACIZUMAB
Active Substance
Bevacizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
-
Frequency
Q3W
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
Mycophenolate mofetil
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
-
Investigational Product Name
INFLIXIMAB
Active Substance
Infliximab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
-
Investigational Product Name
SODIUM CHLORIDE
Active Substance
Sodium chloride
Modality
Other
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
-
Investigational Product Name
DEXTROSE BP
Active Substance
Dextrose BP
Modality
Other
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
-
Combination Treatment
Yes

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