Clinical trial • Phase III • Oncology

nivolumab for Hepatocellular carcinoma

Phase III trial of nivolumab 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
31-01-2024
First CTIS Authorization Date
27-02-2024

Trial design

Randomised, comparator arms: sorafenib (oral; listed as sorafenib 200mg film-coated tablets) and lenvatinib (oral; listed as lenvatinib) as standard of care; specific doses and schedules not specified in provided record.-controlled Phase III trial across 37 sites in Poland, Germany, Italy and others.

Randomised
Yes
Comparator
Comparator arms: Sorafenib (oral; listed as Sorafenib 200mg Film-Coated Tablets) and Lenvatinib (oral; listed as LENVATINIB) as standard of care; specific doses and schedules not specified in provided record.
Target Sample Size
390

Eligibility

Recruits 390 adults.

Inclusion criteria

  • {"criterion_text":"- Participants must have a diagnosis of HCC based on histological confirmation\n- Participants must have an advanced HCC\n- Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion\n- Child-Pugh score 5 or 6\n- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1"}

Exclusion criteria

  • {"criterion_text":"- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n- Prior liver transplant\n- Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization\n- Active brain metastases or leptomeningeal metastases"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- OS, defined as the time between the date of randomization and the date of death (by any cause).","definition_or_measurement_approach":"defined as the time between the date of randomization and the date of death (by any cause)."}

Secondary endpoints

  • {"endpoint_text":"- ORR, defined as the percentage of participants whose BOR is either a confirmed CR or PR.","definition_or_measurement_approach":"defined as the percentage of participants whose best objective response (BOR) is either a confirmed complete response (CR) or partial response (PR)."}
  • {"endpoint_text":"- DOR, defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first","definition_or_measurement_approach":"defined as the time from the first documented evidence of a response (CR or PR) until the first documented disease progression or death from any cause, whichever occurs first."}
  • {"endpoint_text":"- TTSD, defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep.","definition_or_measurement_approach":"defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep."}
  • {"endpoint_text":"- PFS, defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first."}
  • {"endpoint_text":"- TTP, defined as the time from randomization to the first documented disease progression.","definition_or_measurement_approach":"defined as the time from randomization to the first documented disease progression."}

Recruitment

Planned Sample Size
390
Recruitment Window Months
69
Consent Approach
Subject information and informed consent forms (ICFs) are provided (multiple versions listed in the documents), available in multiple languages (including English, French, Italian, Romanian, Polish, Dutch as indicated by document titles). Specific details on who provides consent, assent procedures for minors, and language-specific age-tailored documents are not detailed in the provided record.

Geography

Total Number Of Sites
37
Total Number Of Participants
373

Poland

Earliest CTIS Part Ii Submission Date
27-02-2024
Latest Decision Or Authorization Date
12-03-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
32

Sites

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
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Wojewodzkie Centrum Onkologii, Oddzial Onkologii
Contact Person Name
Joanna Wójcik-Tomaszewska
Contact Person Email
jwojcik@wco.gda.pl
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Szpital im. Fryderyka Chopina, Oddzial Onkologii Klinicznej
Contact Person Name
Cezary Szczylik
Contact Person Email
cezary.szczylik@ecz-otwock.pl

Germany

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
28-02-2024
Processing Time Days
15
Number Of Sites
3
Number Of Participants
31

Sites

Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Medizinische Klinik I
Contact Person Name
Jörg Trojan
Contact Person Email
Trojan@em.uni-frankfurt.de
Site Name
Johannes Gutenberg University Mainz
Department Name
1. Medizinische Klinik und Poliklinik Hepatologie
Contact Person Name
Peter R. Galle
Contact Person Email
Galle@mail.uni-mainz.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik für Gastroenterologie und Hepatologie
Contact Person Name
Dirk-Thomas Waldschmidt
Contact Person Email
Dirk.waldschmidt@uk-koeln.de

Italy

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
01-03-2024
Processing Time Days
17
Number Of Sites
7
Number Of Participants
80

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
U.O. Gastroenterologia ed Epatologia
Contact Person Name
Angelo Sangiovanni
Contact Person Email
Angelo.sangiovanni@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Medicina Interna e Gastroenterologia
Contact Person Name
Antonio Gasbarrini
Contact Person Email
Antonio.gasbarrini@unicatt.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Francesca Negri
Contact Person Email
Francescanegri2@hotmail.com
Site Name
Humanitas Research Hospital
Department Name
Centro di Oncologia e Ematologia
Contact Person Name
Armando Santoro
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
U.O.C Oncologia
Contact Person Name
Giuseppe Aprile
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Divisione di Oncologia Medica
Contact Person Name
Renato Ferraris
Contact Person Email
renato.ferraris@ircc.it
Site Name
Istituto Oncologico Veneto
Department Name
SC Oncologica Medica 1
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it

France

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
04-03-2024
Processing Time Days
20
Number Of Sites
10
Number Of Participants
120

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Digestive Oncology Department
Contact Person Name
Nadim FARES
Contact Person Email
fares.n@chu-toulouse.fr
Site Name
Hopital Paul Brousse
Department Name
Hepato-biliary Centre
Contact Person Name
Olivier ROSMORDUC
Contact Person Email
olivier.rosmorduc@aphp.fr
Site Name
Hopital De La Croix Rousse
Department Name
Hepatology and gastroenterology department
Contact Person Name
Philippe MERLE
Contact Person Email
philippe.merle@inserm.fr
Site Name
CHRU De Nancy
Department Name
Hepato-Gastro-Enterology Department
Contact Person Name
Jean Pierre BRONOWICKI
Contact Person Email
jp.bronowicki@chru-nancy.fr
Site Name
Hopital Beaujon
Department Name
Digestive Oncology Department
Contact Person Name
Mohamed BOUATTOUR
Contact Person Email
Mohamed.bouattour@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Medical Oncology Department
Contact Person Name
Eric ASSENAT
Contact Person Email
e-assenat@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Digestive Oncology Department
Contact Person Name
Jean Frederic BLANC
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Hepato-Gastro-Enterology Department
Contact Person Name
Thomas DECAENS
Contact Person Email
TDecaens@chu-grenoble.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Digestive Oncology Department
Contact Person Name
Francois GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Department of Gastroenterology and Digestive Oncology
Contact Person Name
Albert TRAN
Contact Person Email
tran.a@chu-nice.fr

Belgium

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
12-03-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Hopital Erasme
Department Name
Dept of Gastroenterology/HepatoPancreatology/Digestive Oncology
Contact Person Name
Anne Demols
Contact Person Email
anne.demols@hubruxelles.be

Romania

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
05-03-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
50

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Medical Oncology
Contact Person Name
Adina Croitoru
Contact Person Email
oncologie@icfundeni.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Contact Person Name
Tudor Ciuleanu
Contact Person Email
tudor_ciuleanu@hotmail.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
27-02-2024
Processing Time Days
14
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Contact Person Name
Carlos López López
Contact Person Email
carlos.lopez@scsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Internal Medicine
Contact Person Name
Beatriz Minguez Rosique
Contact Person Email
bminguez@vhebron.net
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Oncology
Contact Person Name
Roberto Antonio Pazo Cid
Contact Person Email
rpazo@salud.aragon.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Miguel Marín Vera
Contact Person Email
miguelmarin75@hotmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Gastroenterology and Hepatology
Contact Person Name
Jose Luis Calleja Panero
Contact Person Email
joseluis.calleja@uam.es
Site Name
Hospital Clinic De Barcelona
Department Name
Liver Unit
Contact Person Name
Maria Elisa Reig
Contact Person Email
mreig@clinic.cat
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Hepatology
Contact Person Name
Delia D'Avola
Contact Person Email
ddavola@unav.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Hepatology
Contact Person Name
Delia D'Avola
Contact Person Email
ddavola@unav.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Gastroenterology
Contact Person Name
Ana María Matilla Peña

Austria

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
08-04-2024
Processing Time Days
55
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine, Division of Gastroenterology and Hepatology
Contact Person Name
Rudolf Stauber
Contact Person Email
rudolf.stauber@medunigraz.at

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Sponsor duties codes: 1,10,11,12,2,6
Name
Icon Laboratory Services Inc.
Responsibilities
Data entry of Local Laboratory Values
Name
Icon (Lr) Limited
Responsibilities
Supply management, kit/supply provision, storage & distribution for analysis, pathology report receipt, PBMC processing

Third parties

  • {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"Specialty Biomarker Lab, Exploratory Serum Biomarkers analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Sponsor duties codes: 1,10,11,12,2,6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Omniseq Inc.","duties_or_roles":"TSO500 testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Measure of Extracellular Matrix markers in serum samples","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"T-cell phenotyping","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Genomic sectioning, H&E test FFPE blocks","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Data entry of Local Laboratory Values","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Spl mngt, Kit/Supply provision, Storage & distrib for anal, pathology report receipt, PBMC processing","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Biomarker expression analysis; duties codes include 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations; duties code 6","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
nivolumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
EU/1/15/1014/001
Maximum Dose
9999 mg
Investigational Product Name
YERVOY 5 mg/ml concentrate for solution for infusion
Active Substance
ipilimumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
EU/1/11/698/002
Maximum Dose
9999 mg
Investigational Product Name
LENVATINIB
Active Substance
lenvatinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
-
Maximum Dose
9999 mg
Investigational Product Name
Sorafenib 200mg Film-Coated Tablets
Active Substance
sorafenib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
PL 00240/0520
Maximum Dose
99999 mg
Combination Treatment
Yes

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