Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for Advanced hepatocellular carcinoma

Phase III trial of RILVEGOSTOMIG for Advanced hepatocellular carcinoma.

Overview

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

Key dates

Initial CTIS Submission Date
10-06-2025
First CTIS Authorization Date
30-09-2025

Trial design

Randomised, open-label, arm c: atezolizumab + bevacizumab; dose and schedule not specified in the ctis record-controlled Phase III trial across 51 sites in Italy, Germany, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm C: Atezolizumab + Bevacizumab; dose and schedule not specified in the CTIS record
Biomarker Stratified
True, PD-L1 expression subgroups
Target Sample Size
947

Eligibility

Recruits 947 adults.

Inclusion criteria

  • {"criterion_text":"- Locally advanced or metastatic and/or unresectable HCC\n- WHO/ECOG performance status of 0 or 1\n- BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A\n- At least one measurable target lesion\n- Co-infected with HBV and HCV are not eligible\n- Adequate organ and bone marrow function measured during the screening period\n- Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.\n- Disease that is not amenable to curative surgical and/or locoregional therapies. Participants who have received approved adjuvant therapy (including immune checkpoint inhibitor treatment) must have a minimum interval of 6 months between the completion of such therapy and the documented diagnosis of recurrent or metastatic disease. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study."}

Exclusion criteria

  • {"criterion_text":"- Any evidence of uncontrolled intercurrent diseases\n- Bleeding or other risks. HCC related - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n- Bleeding or other risks. HCC related - Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)\n- Bleeding or other risks. HCC related - Prior treatment with anti-CTLA-4 and/or anti-TIGIT.\n- Bleeding or other risks. HCC related - Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment\n- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment\n- History of another primary malignancy\n- Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline\n- Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.\n- History of active primary immunodeficiency or active infection\n- History of hepatic encephalopathy\n- Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol\n- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- PFS, ORR, DoR by BICR per RECIST v1.1","definition_or_measurement_approach":"By BICR per RECIST v1.1"}

Recruitment

Planned Sample Size
947
Recruitment Window Months
50
Consent Approach
Informed consent is obtained from adult participants. Subject information and informed consent forms (L1 SIS and ICF) are provided; multiple language-specific ICFs and addenda are included in the documentation (examples in the record include versions in French, Spanish, Dutch, Polish, Italian and English). Specific assent processes for minors are not described in the CTIS record.

Geography

Total Number Of Sites
51
Total Number Of Participants
273

Italy

Earliest CTIS Part Ii Submission Date
23-06-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
289
Number Of Sites
8
Number Of Participants
46

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
PROMISE
Principal Investigator Name
Calogero Cammà
Principal Investigator Email
calogero.camma@unipa.it
Contact Person Name
Calogero Cammà
Contact Person Email
calogero.camma@unipa.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
HepatoPancreatoBiliary Oncology Medical Oncology and Hematology Unit - Humanitas Cancer Center
Principal Investigator Name
Lorenza Rimassa
Principal Investigator Email
lorenza.rimassa@hunimed.eu
Contact Person Name
Lorenza Rimassa
Contact Person Email
lorenza.rimassa@hunimed.eu
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Internal Medicine and Gastroenterology
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
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Oncologia Medica 2
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
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical and Surgical Department of Digestive, Liver and Endocrine-Metabolic Diseases
Principal Investigator Name
Fabio Piscaglia
Principal Investigator Email
fabio.piscaglia@unibo.it
Contact Person Name
Fabio Piscaglia
Contact Person Email
fabio.piscaglia@unibo.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Medical Oncology (SC Oncologia Falck)
Principal Investigator Name
Katia Bruna Bencardino
Principal Investigator Email
katia.bencardino@ospedaleniguarda.it
Contact Person Name
Katia Bruna Bencardino
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO 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
Azienda Ospedaliera Di Perugia
Department Name
Department of Medicai Oncology
Principal Investigator Name
Mario Mandalà
Principal Investigator Email
mario.mandala@unipg.it
Contact Person Name
Mario Mandalà
Contact Person Email
mario.mandala@unipg.it

Germany

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
217
Number Of Sites
16
Number Of Participants
72

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Gastroenterologie, Hepatologie und Transplantationsmedizin
Principal Investigator Name
Leonie Jochheim
Principal Investigator Email
Leonie.Jochheim@uk-essen.de
Contact Person Name
Leonie Jochheim
Contact Person Email
Leonie.Jochheim@uk-essen.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Med. Klinik III Studienzentrum Viszeralonkologie
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
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik 2
Principal Investigator Name
Najib Ben Khaled
Principal Investigator Email
Najib.BenKhaled@med.uni-muenchen.de
Contact Person Name
Najib Ben Khaled
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik I Studienzentrale Internistische Onkologie
Principal Investigator Name
Anke Kroecher nee Froemmel
Principal Investigator Email
Anke.Kroecher@ukdd.de
Contact Person Name
Anke Kroecher nee Froemmel
Contact Person Email
Anke.Kroecher@ukdd.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik 1 Onkologische Gastroenterologie
Principal Investigator Name
Maria Gonzalez-Carmona
Principal Investigator Email
maria.gonzalez-carmona@ukbonn.de
Contact Person Name
Maria Gonzalez-Carmona
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gastroenterologie, Hepatologie, Infektologie, 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
Universitaetsklinikum Ulm AöR
Department Name
Zentrum fuer Innere Medizin Klinik für Innere Medizin I
Principal Investigator Name
Thomas Ettrich
Principal Investigator Email
thomas.ettrich@uniklinik-ulm.de
Contact Person Name
Thomas Ettrich
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Medizinische Klinik und Poliklinik Studienambulanz Hepatologie
Principal Investigator Name
Johann von Felden
Principal Investigator Email
j.von-felden@uke.de
Contact Person Name
Johann von Felden
Contact Person Email
j.von-felden@uke.de
Site Name
Klinikum Dortmund gGmbH
Department Name
Klinik für Gastroenterologie, Hämatologie, Internistische Onkologie und Endokrinologie
Principal Investigator Name
Marcus-Alexander Woerns
Principal Investigator Email
marcus-alexander.woerns@klinikumdo.de
Contact Person Name
Marcus-Alexander Woerns
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Klinik fuer 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
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik I
Principal Investigator Name
Jens Marquardt
Principal Investigator Email
Jens.Marquardt@uksh.de
Contact Person Name
Jens Marquardt
Contact Person Email
Jens.Marquardt@uksh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Principal Investigator Name
Raphael Mohr
Principal Investigator Email
raphael.mohr@charite.de
Contact Person Name
Raphael Mohr
Contact Person Email
raphael.mohr@charite.de
Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
Klinik für Gastroenterologie und Onkologie
Principal Investigator Name
Mischa Franz Moeller
Principal Investigator Email
mischa.moeller@bethanienmoers.de
Contact Person Name
Mischa Franz Moeller
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik I
Principal Investigator Name
Joerg Trojan
Principal Investigator Email
trojan@em.uni-frankfurt.de
Contact Person Name
Joerg Trojan
Contact Person Email
trojan@em.uni-frankfurt.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Principal Investigator Name
Florian van Boemmel
Principal Investigator Email
florian.vanboemmel@medizin.uni-leipzig.de
Contact Person Name
Florian van Boemmel
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Principal Investigator Name
Thorsten Oliver Goetze
Principal Investigator Email
goetze.thorsten@khnw.de
Contact Person Name
Thorsten Oliver Goetze
Contact Person Email
goetze.thorsten@khnw.de

Netherlands

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
221
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Academisch Ziekenhuis Maastricht
Department Name
Medische Oncologie
Principal Investigator Name
Judith de Vos
Principal Investigator Email
judith.de.vos@mumc.nl
Contact Person Name
Judith de Vos
Contact Person Email
judith.de.vos@mumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Medische Oncologie
Principal Investigator Name
Daan Knapen
Principal Investigator Email
d.g.knapen@umcg.nl
Contact Person Name
Daan Knapen
Contact Person Email
d.g.knapen@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medische Oncologie
Principal Investigator Name
Nadia Haj Mohammad
Principal Investigator Email
n.hajmohammad@umcutrecht.nl
Contact Person Name
Nadia Haj Mohammad
Contact Person Email
n.hajmohammad@umcutrecht.nl
Site Name
Erasmus MC
Department Name
Kanker Instituut
Principal Investigator Name
Ferry Eskens
Principal Investigator Email
f.eskens@erasmusmc.nl
Contact Person Name
Ferry Eskens
Contact Person Email
f.eskens@erasmusmc.nl
Site Name
Amsterdam UMC
Department Name
Medical Oncology, locatie Vumc
Principal Investigator Name
Johanna Wilmink
Principal Investigator Email
j.w.wilmink@amsterdamumc.nl
Contact Person Name
Johanna Wilmink
Contact Person Email
j.w.wilmink@amsterdamumc.nl

Poland

Earliest CTIS Part Ii Submission Date
16-09-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
231
Number Of Sites
7
Number Of Participants
40

Sites

Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Klinika Onkologii i Immunologii z Oddzialem Dziennym Terapii Onkologicznej
Principal Investigator Name
Tomasz Lewandowski
Principal Investigator Email
tomasz.lewandowski@poliklinika.net
Contact Person Name
Tomasz Lewandowski
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
I Oddzial Onkologii Klinicznej z Chemioterapia Dzienna
Principal Investigator Name
Aneta Dobrzyńska-Rutkowska
Principal Investigator Email
adobrzynska@cozl.pl
Contact Person Name
Aneta Dobrzyńska-Rutkowska
Contact Person Email
adobrzynska@cozl.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Ewa Szutowicz-Zielinska
Principal Investigator Email
ESZUT@GUMED.EDU.PL
Contact Person Name
Ewa Szutowicz-Zielinska
Contact Person Email
ESZUT@GUMED.EDU.PL
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Zurawski
Principal Investigator Email
zurawskib@co.bydgoszcz.pl
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Lucjan Wyrwicz
Principal Investigator Email
koir@nio.gov.pl
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
koir@nio.gov.pl
Site Name
Szpital Miejski Specjalistyczny Im. Gabriela Narutowicza W Krakowie
Department Name
Oddzial Kliniczny Onkologii Klinicznej i Chemioterapii
Principal Investigator Name
Joanna Streb
Principal Investigator Email
dilo@narutowicz.krakow.pl
Contact Person Name
Joanna Streb
Contact Person Email
dilo@narutowicz.krakow.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
sekretariat.odch@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl

France

Earliest CTIS Part Ii Submission Date
22-08-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
234
Number Of Sites
8
Number Of Participants
48

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pôle de référence 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
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical Oncology
Principal Investigator Name
Julien Edeline
Principal Investigator Email
j.edeline@rennes.unicancer.fr
Contact Person Name
Julien Edeline
Contact Person Email
j.edeline@rennes.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service Hépatologie
Principal Investigator Name
Jean-Marie Péron
Principal Investigator Email
peron.jm@chu-toulouse.fr
Contact Person Name
Jean-Marie Péron
Contact Person Email
peron.jm@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncology medical department
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
Assistance Publique Hopitaux De Paris
Department Name
Liver cancer and Therapeutic Innovation Unit
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 De Lille
Department Name
Service des Maladies de l'Appareil Digestif et de la Nutrition
Principal Investigator Name
Philippe Mathurin
Principal Investigator Email
philippe.mathurin@chu-lille.fr
Contact Person Name
Philippe Mathurin
Contact Person Email
philippe.mathurin@chu-lille.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncology
Principal Investigator Name
Philippe Merle
Principal Investigator Email
philippe.merle@chu-lyon.fr
Contact Person Name
Philippe Merle
Contact Person Email
philippe.merle@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Digestive Oncology
Principal Investigator Name
Jean-Frédéric Blanc
Principal Investigator Email
jean-frederic.blanc@chu-bordeaux.fr
Contact Person Name
Jean-Frédéric Blanc

Spain

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
294
Number Of Sites
7
Number Of Participants
40

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Digestive
Principal Investigator Name
María Elisa Reig
Principal Investigator Email
mreig1@clinic.cat
Contact Person Name
María Elisa Reig
Contact Person Email
mreig1@clinic.cat
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Ángela Lamarca Lete
Principal Investigator Email
angela.lamarca@quironsalud.es
Contact Person Name
Ángela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Digestive
Principal Investigator Name
Ana Matilla Peña
Principal Investigator Email
anamatillapena@gmail.com
Contact Person Name
Ana Matilla Peña
Contact Person Email
anamatillapena@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Principal Investigator Name
Carlos López López
Principal Investigator Email
Carlos.lopez@scsalud.es
Contact Person Name
Carlos López López
Contact Person Email
Carlos.lopez@scsalud.es
Site Name
Clinica Universidad De Navarra
Department Name
Digestive
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 Universitari Vall D Hebron
Department Name
Digestive
Principal Investigator Name
Beatriz Mínguez Rosique
Principal Investigator Email
bminguez@vhebron.net
Contact Person Name
Beatriz Mínguez Rosique
Contact Person Email
bminguez@vhebron.net
Site Name
Hospital Universitario Marques De Valdecilla (duplicate listing in record may represent a different department)
Department Name
Oncology
Principal Investigator Name
Carlos López López
Principal Investigator Email
Carlos.lopez@scsalud.es
Contact Person Name
Carlos López López
Contact Person Email
Carlos.lopez@scsalud.es

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Rilvegostomig
Active Substance
RILVEGOSTOMIG
Modality
Bispecific antibody
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
IMJUDO (tremelimumab)
Active Substance
TREMELIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
EU/1/22/1713/002
Investigational Product Name
Bevacizumab
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
Atezolizumab
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
Infliximab
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
Mycophenolate mofetil
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Combination Treatment
Yes

Related trials

Other published trials that may interest you.