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A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave150)

Primary Purpose

Carcinoma, Hepatocellular

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Atezolizumab

Bevacizumab

Sorafenib

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization.
At least one measurable untreated lesion
ECOG Performance Status of 0 or 1
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent
For men: agreement to remain abstinent
Child-Pugh class A

Exclusion Criteria:

History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
Known active tuberculosis
History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
Moderate or severe ascites
History of hepatic encephalopathy
Co-infection of HBV and HCV
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled or symptomatic hypercalcemia
Treatment with systemic immunostimulatory agents
Inadequately controlled arterial hypertension
Prior history of hypertensive crisis or hypertensive encephalopathy
Evidence of bleeding diathesis or significant coagulopathy
History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

Sites / Locations

St. Josephs Hospital and Medical Center
City of Hope
Uni of California - San Diego; Cancer Center & Dept of Medicine
Kaiser Permanente Northern California
University of California Irvine Medical Center
Kaiser Permanente Sacramento Medical Center
California Pacific Medical Center
Kaiser Permanente - San Francisco Medical Center
University of California Los Angeles
Kaiser Permanente - Walnut Creek
Banner MD Anderson Cancer Center
Georgetown University
Moffitt Cancer Center
Massachusetts General Hospital
Henry Ford Health System
Washington University; Wash Uni. Sch. Of Med
University of New Mexico Comprehensive Cancer Center
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
Thomas Jefferson University
M.D Anderson Cancer Center; Uni of Texas At Houston
Swedish Cancer Inst.
Bankstown-Lidcombe Hospital
St George Hospital
The Queen Elizabeth Hospital
Sunshine Hospital
Ottawa Hospital Research Institute
Centre hospitalier de l'Universite de Montreal (CHUM)
Jewish General Hospital
McGill University Health Centre - Glen Site
Peking Union Medical College Hospital
Beijing Friendship Hospital
Beijing Cancer Hospital
the First Hospital of Jilin University
Jilin Cancer Hospital
Hunan Cancer Hospital
The First People's Hospital of Foshan; Local Ethic Committee
The 900th Hospital of PLA joint service support force
Sun Yet-sen University Cancer Center
Nanfang Hospital, Southern Medical University
Sir Run Run Shaw Hospital
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
The First Affiliated Hospital of College of Medicine, Zhejiang University
Harbin Medical University Cancer Hospital
Anhui Province Cancer Hospital
The First Affiliated Hospital of Anhui Medical University
General Hospital of Jinan Military Command of PLA
The 81st Hospital of P.L.A.
Fudan University Shanghai Cancer Center
Zhongshan Hospital Fudan University
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Masarykuv onkologicky ustav
Fakultni nemocnice Olomouc; Onkologicka klinika
Hopital Claude Huriez;Gastro Enterologie
Hopital De La Croix Rousse; Hepatologie Gastro Enterologie
Hopital Timone Adultes; Gastro Enterologie
Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie
Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie
CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie
Hopital Charles Nicolle; Gastroenterologie
Hopital Hautepierre; Gastro Enterologie
Hôpital d'Adultes; Service hépato-gastro-entérologie
Institut Gustave Roussy; Gastro-Enterologie
Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie
Med. Hochschule Hannover; Gastroenterologie
Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.
Uniklinik Mainz; I. Medizinische Klinik
Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
Queen Mary Hospital; Dept. Of Haematology & Oncology
Prince of Wales Hosp; Dept. Of Clinical Onc
Az. Osp. Rummo; Oncologia Medica
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica
A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Chiba University Hospital
National Cancer Center Hospital East
Kurume University Hospital
Sapporo Kosei Genaral Hospital
Hokkaido University Hospital
Kanazawa University Hospital
Kitasato University Hospital
Kumamoto University Hospital
Osaka Metropolitan University Hospital
Kindai University Hospital
Saga-ken Medical Centre Koseikan
Shizuoka Cancer Center
Japanese Red Cross Musashino Hospital
Chonnam National University Hwasun Hospital
Seoul National University Hospital
Severance Hospital, Yonsei University Health System
Asan Medical Center
Samsung Medical Center
Ulsan University Hosiptal
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
ID Clinic
SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
FSBI "National Medical Research Center of Oncology N.N. Blokhin?; Clinical Biotechnologies
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
National Cancer Centre
Tan Tock Seng Hospital; Oncology
Hospital Universitari Vall d'Hebron; Oncology
Hospital Clinico San Carlos; Servicio de Oncologia
Hospital Universitario La Paz; Servicio de Oncologia
Centro Integral Oncologico Clara Campal; Servicio de Oncología
Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
National Cheng Kung University Hospital; Oncology
Chi-Mei Medical Centre; Hematology & Oncology
Veterans General Hospital; Cancer Center
National Taiwan Uni Hospital; Dept of Oncology
Chang Gung Memorial Hospital-Linkou; Dept of Oncology
Beatson West of Scotland Cancer Centre
Royal Free Hospital; Dept of Oncology
King'S College Hospital
Christie Hospital Nhs Trust; Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atezolizumab + Bevacizumab

Sorafenib

Arm Description

Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator

Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator

Outcomes

Primary Outcome Measures

Overall Survival (OS) in the Global Population

OS was defined as the time from randomization to death from any cause.

Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population

PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

Overall Survival (OS) in the China Population

OS was defined as the time from randomization to death from any cause.

PFS-IRF Per RECIST v1.1 in the China Population

Secondary Outcome Measures

Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population

ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population

ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population

ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

PFS-IRF Per HCC mRECIST in the Global Population

PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population

PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population

Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

TTP-IRF Per HCC mRECIST in the Global Population

Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population

Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).

Overall Survival by Baseline AFP in the Global Population

OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP <400 ng/mL and AFP>/= 400 ng/mL were analyzed.

PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population

PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). Subpopulations with baseline AFP <400 ng/mL and AFP>/= 400 ng/mL were analyzed.

PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population

Time to Deterioration (TTD) in the Global Population

TTD was defined as the time from randomization to the first deterioration (decrease from baseline of >/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.

Number of Participants With Adverse Events (AEs) in the Global Population

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population

Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population

Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population

Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population

ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population

Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population

Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

PFS-IRF Per HCC mRECIST in the China Population

PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population

Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population

TTP-IRF Per HCC mRECIST in the China Population

TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population

Time to Deterioration (TTD) in the China Population

Number of Participants With Adverse Events (AEs) in the China Population

Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population

Trough Serum Concentration (Cmin) of Atezolizumab in the China Population

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population

Full Information

NCT ID

NCT03434379

First Posted

January 31, 2018

Last Updated

October 5, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03434379

Brief Title

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Acronym

IMbrave150

Official Title

A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

March 15, 2018 (Actual)

Primary Completion Date

August 31, 2020 (Actual)

Study Completion Date

November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

Detailed Description

The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

558 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atezolizumab + Bevacizumab

Arm Type

Experimental

Arm Description

Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator

Arm Title

Sorafenib

Arm Type

Active Comparator

Arm Description

Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator

Intervention Type

Drug

Intervention Name(s)

Atezolizumab

Intervention Description

Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle

Primary Outcome Measure Information:

Title

Overall Survival (OS) in the Global Population

Description

OS was defined as the time from randomization to death from any cause.

Time Frame

From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)

Title

Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Overall Survival (OS) in the China Population

Description

OS was defined as the time from randomization to death from any cause.

Time Frame

From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)

Title

PFS-IRF Per RECIST v1.1 in the China Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Secondary Outcome Measure Information:

Title

Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population

Description

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population

Description

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

PFS-IRF Per HCC mRECIST in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

TTP-IRF Per HCC mRECIST in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Overall Survival by Baseline AFP in the Global Population

Description

OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP <400 ng/mL and AFP>/= 400 ng/mL were analyzed.

Time Frame

From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Time to Deterioration (TTD) in the Global Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Number of Participants With Adverse Events (AEs) in the Global Population

Description

Time Frame

Up to end of study (up to approximately 56 months)

Title

Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population

Time Frame

Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)

Title

Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population

Time Frame

Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)

Title

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population

Time Frame

Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)

Title

Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population

Description

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population

Description

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population

Description

DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.

Time Frame

Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

PFS-IRF Per HCC mRECIST in the China Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

TTP-IRF Per HCC mRECIST in the China Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Time to Deterioration (TTD) in the China Population

Description

Time Frame

Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

Title

Number of Participants With Adverse Events (AEs) in the China Population

Description

Time Frame

Up to end of study (up to approximately 56 months)

Title

Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population

Time Frame

Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)

Title

Trough Serum Concentration (Cmin) of Atezolizumab in the China Population

Time Frame

Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)

Title

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population

Time Frame

Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization. At least one measurable untreated lesion ECOG Performance Status of 0 or 1 Adequate hematologic and end-organ function For women of childbearing potential: agreement to remain abstinent For men: agreement to remain abstinent Child-Pugh class A Exclusion Criteria: History of leptomeningeal disease Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan Known active tuberculosis History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment. Moderate or severe ascites History of hepatic encephalopathy Co-infection of HBV and HCV Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Treatment with systemic immunostimulatory agents Inadequately controlled arterial hypertension Prior history of hypertensive crisis or hypertensive encephalopathy Evidence of bleeding diathesis or significant coagulopathy History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

St. Josephs Hospital and Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85260

Country

United States

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Uni of California - San Diego; Cancer Center & Dept of Medicine

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Kaiser Permanente Northern California

City

Novato

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

University of California Irvine Medical Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Kaiser Permanente Sacramento Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

California Pacific Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Kaiser Permanente - San Francisco Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

Facility Name

University of California Los Angeles

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Kaiser Permanente - Walnut Creek

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94596

Country

United States

Facility Name

Banner MD Anderson Cancer Center

City

Greeley

State/Province

Colorado

ZIP/Postal Code

85234

Country

United States

Facility Name

Georgetown University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Washington University; Wash Uni. Sch. Of Med

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University of New Mexico Comprehensive Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

M.D Anderson Cancer Center; Uni of Texas At Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Swedish Cancer Inst.

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Bankstown-Lidcombe Hospital

City

Bankstown

State/Province

New South Wales

ZIP/Postal Code

2200

Country

Australia

Facility Name

St George Hospital

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

The Queen Elizabeth Hospital

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Sunshine Hospital

City

St Albans

State/Province

Victoria

ZIP/Postal Code

3021

Country

Australia

Facility Name

Ottawa Hospital Research Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

Facility Name

Centre hospitalier de l'Universite de Montreal (CHUM)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

McGill University Health Centre - Glen Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Peking Union Medical College Hospital

City

Beijing City

ZIP/Postal Code

100032

Country

China

Facility Name

Beijing Friendship Hospital

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

the First Hospital of Jilin University

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Jilin Cancer Hospital

City

Changchun

ZIP/Postal Code

132013

Country

China

Facility Name

Hunan Cancer Hospital

City

Changsha CITY

ZIP/Postal Code

410013

Country

China

Facility Name

The First People's Hospital of Foshan; Local Ethic Committee

City

Foshan

ZIP/Postal Code

510000

Country

China

Facility Name

The 900th Hospital of PLA joint service support force

City

Fuzhou

ZIP/Postal Code

110016

Country

China

Facility Name

Sun Yet-sen University Cancer Center

City

Guangzhou City

ZIP/Postal Code

510663

Country

China

Facility Name

Nanfang Hospital, Southern Medical University

City

Guangzhou

ZIP/Postal Code

510515

Country

China

Facility Name

Sir Run Run Shaw Hospital

City

Hangzhou City

ZIP/Postal Code

310018

Country

China

Facility Name

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

City

Hangzhou City

ZIP/Postal Code

310022

Country

China

Facility Name

The First Affiliated Hospital of College of Medicine, Zhejiang University

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Anhui Province Cancer Hospital

City

Hefei City

ZIP/Postal Code

230031

Country

China

Facility Name

The First Affiliated Hospital of Anhui Medical University

City

Hefei

ZIP/Postal Code

230022

Country

China

Facility Name

General Hospital of Jinan Military Command of PLA

City

Jinan

ZIP/Postal Code

250031

Country

China

Facility Name

The 81st Hospital of P.L.A.

City

Nanjing City

ZIP/Postal Code

210002

Country

China

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai City

ZIP/Postal Code

200120

Country

China

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

City

Wuhan

ZIP/Postal Code

430030

Country

China

Facility Name

Masarykuv onkologicky ustav

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc; Onkologicka klinika

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Hopital Claude Huriez;Gastro Enterologie

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

City

Lyon

ZIP/Postal Code

69317

Country

France

Facility Name

Hopital Timone Adultes; Gastro Enterologie

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie

City

Nice Cedex

ZIP/Postal Code

06202

Country

France

Facility Name

Hopital Charles Nicolle; Gastroenterologie

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

Hopital Hautepierre; Gastro Enterologie

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Hôpital d'Adultes; Service hépato-gastro-entérologie

City

Vandoeuvre-les-nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Institut Gustave Roussy; Gastro-Enterologie

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Med. Hochschule Hannover; Gastroenterologie

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Uniklinik Mainz; I. Medizinische Klinik

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Queen Mary Hospital; Dept. Of Haematology & Oncology

City

Hong Kong

Country

Hong Kong

Facility Name

Prince of Wales Hosp; Dept. Of Clinical Onc

City

Shatin

Country

Hong Kong

Facility Name

Az. Osp. Rummo; Oncologia Medica

City

Benevento

State/Province

Campania

ZIP/Postal Code

82100

Country

Italy

Facility Name

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

City

Meldola

State/Province

Emilia-Romagna

ZIP/Postal Code

47014

Country

Italy

Facility Name

Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica

City

Orbassano

State/Province

Piemonte

ZIP/Postal Code

10043

Country

Italy

Facility Name

A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

City

Cagliari

State/Province

Sardegna

ZIP/Postal Code

09100

Country

Italy

Facility Name

Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56126

Country

Italy

Facility Name

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

Chiba University Hospital

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

National Cancer Center Hospital East

City

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Kurume University Hospital

City

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Sapporo Kosei Genaral Hospital

City

Hokkaido

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

Hokkaido University Hospital

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Kanazawa University Hospital

City

Ishikawa

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Kitasato University Hospital

City

Kanagawa

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Kumamoto University Hospital

City

Kumamoto

ZIP/Postal Code

860-8556

Country

Japan

Facility Name

Osaka Metropolitan University Hospital

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Kindai University Hospital

City

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Saga-ken Medical Centre Koseikan

City

Saga

ZIP/Postal Code

840-8571

Country

Japan

Facility Name

Shizuoka Cancer Center

City

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Japanese Red Cross Musashino Hospital

City

Tokyo

ZIP/Postal Code

180-8610

Country

Japan

Facility Name

Chonnam National University Hwasun Hospital

City

Jeollanam-do

ZIP/Postal Code

58128

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Ulsan University Hosiptal

City

Ulsan

ZIP/Postal Code

44033

Country

Korea, Republic of

Facility Name

Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

ID Clinic

City

Myslowice

ZIP/Postal Code

41-400

Country

Poland

Facility Name

SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii

City

Wroc?aw

ZIP/Postal Code

53-413

Country

Poland

Facility Name

FSBI "National Medical Research Center of Oncology N.N. Blokhin?; Clinical Biotechnologies

City

Moscow

State/Province

Moskovskaja Oblast

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

City

Saint Petersburg

State/Province

Sankt Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

National Cancer Centre

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Tan Tock Seng Hospital; Oncology

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Hospital Universitari Vall d'Hebron; Oncology

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clinico San Carlos; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario La Paz; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Centro Integral Oncologico Clara Campal; Servicio de Oncología

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Universitario Miguel Servet; Servicio de Oncologia Medica

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

National Cheng Kung University Hospital; Oncology

City

Tainan

ZIP/Postal Code

00704

Country

Taiwan

Facility Name

Chi-Mei Medical Centre; Hematology & Oncology

City

Tainan

ZIP/Postal Code

710

Country

Taiwan

Facility Name

Veterans General Hospital; Cancer Center

City

Taipei

ZIP/Postal Code

00112

Country

Taiwan

Facility Name

National Taiwan Uni Hospital; Dept of Oncology

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital-Linkou; Dept of Oncology

City

Taoyuan County

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Beatson West of Scotland Cancer Centre

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Royal Free Hospital; Dept of Oncology

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

King'S College Hospital

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Christie Hospital Nhs Trust; Medical Oncology

City

Manchester

ZIP/Postal Code

M2O 4BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Citations:

PubMed Identifier

36254201

Citation

Kaseb AO, Guan Y, Gok Yavuz B, Abbas AR, Lu S, Hasanov E, Toh HC, Verret W, Wang Y. Serum IGF-1 Scores and Clinical Outcomes in the Phase III IMbrave150 Study of Atezolizumab Plus Bevacizumab versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2022 Oct 11;9:1065-1079. doi: 10.2147/JHC.S369951. eCollection 2022.

Results Reference

derived

PubMed Identifier

36111952

Citation

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A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

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