Clinical trial • Phase III • Oncology
ATEZOLIZUMAB for High-risk hepatocellular carcinoma (HCC)|Hepatocellular carcinoma
Phase III trial of ATEZOLIZUMAB for High-risk hepatocellular carcinoma (HCC)|Hepatocellular carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- High-risk hepatocellular carcinoma (HCC)|Hepatocellular carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 09-05-2024
- First CTIS Authorization Date
- 12-06-2024
Trial design
Randomised, open-label, arm a: atezolizumab 1200 mg iv q3w + bevacizumab 15 mg/kg iv q3w; arm b: active surveillance-controlled Phase III trial in Netherlands, France, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arm A: atezolizumab 1200 mg IV Q3W + bevacizumab 15 mg/kg IV Q3W; Arm B: active surveillance
- Target Sample Size
- 596
- Trial Duration For Participant
- 365
Eligibility
Recruits 596 adults.
Inclusion criteria
- {"criterion_text":"- Participants with a first diagnosis of HCC who have undergone either curative resection or ablation (RFS or MWA only) within 4-12 weeks prior to randomization"}
- {"criterion_text":"- High risk for HCC recurrence after resection or ablation"}
- {"criterion_text":"- Full recovery from surgical resection or ablation within 4 weeks prior to randomization"}
- {"criterion_text":"- Absence of MVI (Vp3 or Vp4)"}
- {"criterion_text":"- ECOG Performance Status of 0 or 1"}
- {"criterion_text":"- Child-Pugh Class A status"}
Exclusion criteria
- {"criterion_text":"- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC"}
- {"criterion_text":"- Evidence of residual, recurrent, or metastatic disease at randomization"}
- {"criterion_text":"- On the waiting list for liver transplant"}
- {"criterion_text":"- History of hepatic encephalopathy"}
- {"criterion_text":"- Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization"}
- {"criterion_text":"- Have received more than 1 cycle of adjuvant TACE following surgical resection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Independent Review Facility (IRF)-assessed recurrence-free survival (RFS)","definition_or_measurement_approach":"Recurrence-free survival (RFS) as determined/assessed by an Independent Review Facility (IRF)"}
Secondary endpoints
- {"endpoint_text":"- 1. Overall Survival (OS) rate at 24 months and 36 months","definition_or_measurement_approach":"Overall survival (OS) rate at specified timepoints (24 and 36 months)"}
- {"endpoint_text":"- 2. OS","definition_or_measurement_approach":"Overall survival (OS)"}
- {"endpoint_text":"- 3. RFS as determined by the investigator","definition_or_measurement_approach":"Recurrence-free survival (RFS) assessed by the investigator"}
- {"endpoint_text":"- 4. Time to Recurrence (TTR)","definition_or_measurement_approach":"Time from randomization to recurrence (TTR)"}
- {"endpoint_text":"- 5. Time to extrahepatic spread (EHS) or macrovascular invasion","definition_or_measurement_approach":"Time to extrahepatic spread (EHS) or macrovascular invasion"}
- {"endpoint_text":"- 6. RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup","definition_or_measurement_approach":"RFS assessed by investigator and IRF in PD-L1-high subgroup"}
- {"endpoint_text":"- 7. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0","definition_or_measurement_approach":"Adverse events graded using NCI CTCAE v5.0"}
- {"endpoint_text":"- 8. Change from baseline in targeted vital signs","definition_or_measurement_approach":"Change from baseline in prespecified vital signs"}
- {"endpoint_text":"- 9. Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in prespecified clinical laboratory parameters"}
- {"endpoint_text":"- 10. Serum concentration of atezolizumab at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentration of atezolizumab at defined timepoints"}
- {"endpoint_text":"- 11. Prevalence of anti-drug antibody (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study","definition_or_measurement_approach":"Immunogenicity assessments: prevalence at baseline and incidence during study"}
- {"endpoint_text":"- 12. IRF-assessed RFS and investigator-assessed RFS rate at 24 and 36 months after randomization","definition_or_measurement_approach":"RFS rates at 24 and 36 months assessed by IRF and investigator"}
Recruitment
- Planned Sample Size
- 596
- Recruitment Window Months
- 88
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 72
Netherlands
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 18-06-2024
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Oncology
- Contact Person Name
- Judith de Vos-Geelen
- Contact Person Email
- Judith.de.vos@mumc.nl
France
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 8
- Number Of Sites
- 8
- Number Of Participants
- 37
Sites
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- service Hepato gastro enterologie
- Contact Person Name
- Alexandra HEURGUE
- Contact Person Email
- aheurgue@chu-reims.fr
- Site Name
- CHRU De Nancy
- Department Name
- Hépato-gastroentérologie
- Contact Person Name
- Jean-Pierre BRONOWICKI
- Contact Person Email
- jp.bronowicki@chru-nancy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'hépatologie
- Contact Person Name
- Nathalie GANNE
- Contact Person Email
- nathalie.ganne@aphp.fr
- Site Name
- Hopital Saint Joseph
- Department Name
- Service Hépato-Gastroentérologie
- Contact Person Name
- Marc BOURLIERE
- Contact Person Email
- mbourliere@hopital-saint-joseph.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Service Hepato-gastroenterologie
- Contact Person Name
- Thomas DECAENS
- Contact Person Email
- tdecaens@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service d'Oncologie Digestive
- Contact Person Name
- Jean-Frédéric BLANC
- Contact Person Email
- jean-frederic.blanc@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service Hépatologie Pôle digestif
- Contact Person Name
- Jean Marie PERON
- Contact Person Email
- peron.jm@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service des Maladies du Foie
- Contact Person Name
- Thomas UGUEN
- Contact Person Email
- Thomas.UGUEN@chu-rennes.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 12
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
- Department Name
- Divisione di Medicina VI
- Contact Person Name
- Pier Maria Battezzati
- Contact Person Email
- piermaria.battezzati@unimi.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
- Contact Person Name
- Gianluca Masi
- Contact Person Email
- gianluca.masi@unipi.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- OSPEDALE REGIONALE DI PARMA; DIVISIONE DI ONCOLOGIA MEDICA
- Contact Person Name
- Ingrid Garajova
- Contact Person Email
- igarajova@ao.pr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 7
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Oncology
- Contact Person Name
- Ignacio Delgado
- Contact Person Email
- jignacio.delgado@salud-juntaex.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Grastroenterology
- Contact Person Name
- Jose Luis Calleja
- Contact Person Email
- jlcallejap@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- onkologická klinika
- Contact Person Name
- Eugen Kubala
- Contact Person Email
- eugen.kubala@ftn.cz
Austria
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 33
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Landeskrankenanstalten-Betriebsgesellschaft Kabeg
- Department Name
- Dept of Internal Medicine & Gastroenterology, Hepatology, Endocrinology, Rheumatology & Nephrology
- Contact Person Name
- Markus Peck-Radosavljevic
- Contact Person Email
- imugast.klagenfurt@kabeg.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Medicine III
- Contact Person Name
- Matthias Pinter
- Contact Person Email
- postakhi3mgh@akhwien.at
Germany
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 12
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Zentrum Innere Medizin; Med. Klinik I
- Contact Person Name
- Jörg Trojan
- Contact Person Email
- trojan@em.uni-frankfurt.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
- Contact Person Name
- Arne Kandulski
- Contact Person Email
- arne.kandulski@ukr.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Zentrum für Innere Medizin Klinik für Innere Medizin I
- Contact Person Name
- Thomas Ettrich
- Contact Person Email
- thomas.ettrich@uniklinik-ulm.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Gastroenterology
- Contact Person Name
- Jochen Decaestecker
- Contact Person Email
- ctc.mdl@azdelta.be
Poland
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Onkologii i Radioterapii
- Contact Person Name
- Maciej Kawecki
- Contact Person Email
- maciej.kawecki@nio.gov.pl
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Development Solutions LLC
- Responsibilities
- code:4
- Name
- PPD Development LP
- Responsibilities
- code:4
- Name
- IQVIA Limited
- Responsibilities
- code:15; value: Monitoring
- Name
- Syneos Health Inc.
- Responsibilities
- code:6
- Name
- Almac Pharma Services Limited
- Responsibilities
- code:3
Third parties
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Pharma Services Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"code:15; value: Imaging Independent Review Facility (IRF)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:15; value: Monitoring","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/17/1220/001)
- Starting Dose
- 1200 mg
- Frequency
- Q3W
- Maximum Dose
- 1200 mg
- Investigational Product Name
- Avastin 25 mg/ml concentrate for solution for infusion.
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/04/300/002)
- Starting Dose
- 15 mg/kg
- Frequency
- Q3W
- Maximum Dose
- 15 mg/kg
- Combination Treatment
- Yes
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