Carcinoma, HepatocellularPhase 3IMbrave150NCT03434379
A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
A Phase 3 study testing Atezolizumab, Bevacizumab and Sorafenib in people with Carcinoma, Hepatocellular, run by Hoffmann-La Roche at 119 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Atezolizumab, Bevacizumab and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 119 sitesin 17 countries
- Study dates
- 15 Mar 2018to 17 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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)
Trial locations and contacts
119 sites in 17 countries.
119 sites in 17 countries
United States21 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
Massachusetts General Hospital
Boston, Massachusetts, 02114
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope
Duarte, California, 91010
Banner MD Anderson Cancer Center
Greeley, Colorado, 85234
M.D Anderson Cancer Center; Uni of Texas At Houston
Houston, Texas, 77030
Uni of California - San Diego; Cancer Center & Dept of Medicine
La Jolla, California, 92093
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, 10016
Kaiser Permanente Northern California
Novato, California, 94589
University of California Irvine Medical Center
Orange, California, 92868
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St. Josephs Hospital and Medical Center
Phoenix, Arizona, 85260
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
California Pacific Medical Center
San Francisco, California, 94115
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, 94118
University of California Los Angeles
Santa Monica, California, 90404
Swedish Cancer Inst.
Seattle, Washington, 98104
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
Kaiser Permanente - Walnut Creek
Walnut Creek, California, 94596
Georgetown University
Washington D.C., District of Columbia, 20007
China21 sites
Peking Union Medical College Hospital
Beijing, 100032
Beijing Friendship Hospital
Beijing, 100050
Beijing Cancer Hospital
Beijing, 100142
the First Hospital of Jilin University
Changchun, 130021
Jilin Cancer Hospital
Changchun, 132013
Hunan Cancer Hospital
Changsha, 410013
The First People's Hospital of Foshan; Local Ethic Committee
Foshan, 510000
The 900th Hospital of PLA joint service support force
Fuzhou, 110016
Nanfang Hospital, Southern Medical University
Guangzhou, 510515
Sun Yet-sen University Cancer Center
Guangzhou, 510663
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003
Sir Run Run Shaw Hospital
Hangzhou, 310018
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
Anhui Province Cancer Hospital
Hefei, 230031
General Hospital of Jinan Military Command of PLA
Jinan, 250031
The 81st Hospital of P.L.A.
Nanjing, 210002
Zhongshan Hospital Fudan University
Shanghai, 200032
Fudan University Shanghai Cancer Center
Shanghai, 200120
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030
Japan13 sites
Chiba University Hospital
Chiba, 260-8677
National Cancer Center Hospital East
Chiba, 277-8577
Kurume University Hospital
Fukuoka, 830-0011
Sapporo Kosei Genaral Hospital
Hokkaido, 060-0033
Hokkaido University Hospital
Hokkaido, 060-8648
Kanazawa University Hospital
Ishikawa, 920-8641
Kitasato University Hospital
Kanagawa, 252-0375
Kumamoto University Hospital
Kumamoto, 860-8556
Osaka Metropolitan University Hospital
Osaka, 545-8586
Kindai University Hospital
Osaka, 589-8511
Saga-ken Medical Centre Koseikan
Saga, 840-8571
Shizuoka Cancer Center
Shizuoka, 411-8777
Japanese Red Cross Musashino Hospital
Tokyo, 180-8610
France10 sites
Hopital Claude Huriez;Gastro Enterologie
Lille, 59037
Hopital De La Croix Rousse; Hepatologie Gastro Enterologie
Lyon, 69317
Hopital Timone Adultes; Gastro Enterologie
Marseille, 13385
Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie
Montpellier, 34295
Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie
Nantes, 44093
CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie
Nice, 06202
Hopital Charles Nicolle; Gastroenterologie
Rouen, 76031
Hopital Hautepierre; Gastro Enterologie
Strasbourg, 67098
Hôpital d'Adultes; Service hépato-gastro-entérologie
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy; Gastro-Enterologie
Villejuif, 94805
Germany7 sites
Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie
Berlin, 13353
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt, 60590
Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie
Hamburg, 20246
Med. Hochschule Hannover; Gastroenterologie
Hanover, 30625
Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.
Leipzig, 04103
Uniklinik Mainz; I. Medizinische Klinik
Mainz, 55131
Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
Regensburg, 93053
Italy6 sites
Az. Osp. Rummo; Oncologia Medica
Benevento, Campania, 82100
A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
Cagliari, Sardinia, 09100
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014
Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica
Orbassano, Piedmont, 10043
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padova, Veneto, 35128
Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico
Pisa, Tuscany, 56126
South Korea6 sites
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Ulsan University Hosiptal
Ulsan, 44033
Poland5 sites
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, 80-219
ID Clinic
Mysłowice, 41-400
SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY
Olsztyn, 10-228
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
Warsaw, 02-781
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
Wroc?aw, 53-413
Spain5 sites
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, 08035
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, 28040
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046
Centro Integral Oncologico Clara Campal; Servicio de Oncología
Madrid, 28050
Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
Zaragoza, 50009
Taiwan5 sites
National Cheng Kung University Hospital; Oncology
Tainan, 00704
Chi-Mei Medical Centre; Hematology & Oncology
Tainan, 710
Veterans General Hospital; Cancer Center
Taipei, 00112
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100
Chang Gung Memorial Hospital-Linkou; Dept of Oncology
Taoyuan County, 333
Australia4 sites
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200
St George Hospital
Kogarah, New South Wales, 2217
Sunshine Hospital
St Albans, Victoria, 3021
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
Canada4 sites
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
United Kingdom4 sites
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Royal Free Hospital; Dept of Oncology
London, NW3 2QG
King'S College Hospital
London, SE5 9RS
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX
Czechia2 sites
Masarykuv onkologicky ustav
Brno, 656 53
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00
Hong Kong2 sites
Queen Mary Hospital; Dept. Of Haematology & Oncology
Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin
Russia2 sites
FSBI "National Medical Research Center of Oncology N.N. Blokhin?; Clinical Biotechnologies
Moscow, Moscow Oblast, 115478
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, Sankt-Peterburg, 197758
Singapore2 sites
National Cancer Centre
Singapore, 169610
Tan Tock Seng Hospital; Oncology
Singapore, 308433
About this study
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
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.
Read the 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
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Atezolizumab, Bevacizumab, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
BevacizumabDrug
Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
SorafenibDrug
Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab + Bevacizumab | Experimental | Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator Receives: Drug: Atezolizumab; Drug: Bevacizumab |
| Sorafenib | Active comparator | Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) in the Global Population
OS was defined as the time from randomization to death from any cause.
Measured: 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)
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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Overall Survival (OS) in the China Population
OS was defined as the time from randomization to death from any cause.
Measured: 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)
PFS-IRF Per RECIST v1.1 in the China 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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcomes (35)
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
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-INV 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 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). Subpopulations with baseline AFP <400 ng/mL and AFP>/= 400 ng/mL were analyzed.
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Up to end of study (up to approximately 56 months)
Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
Measured: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
Measured: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
Measured: 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)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China 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
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China 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
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China 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
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF-Assessment (DOR-IRF) 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 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.
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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.
Measured: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-IRF Per HCC mRECIST in the China 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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China 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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China 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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
TTP-IRF Per HCC mRECIST in the China 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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China 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).
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Time to Deterioration (TTD) in the China 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.
Measured: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Number of Participants With Adverse Events (AEs) in the China 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.
Measured: Up to end of study (up to approximately 56 months)
Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
Measured: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Measured: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start15 Mar 2018
- Primary completion31 Aug 2020
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434379
- Sponsor's protocol ID
- YO40245
- Other IDs
- 2017-003691-31, 2017
- Acronym
- IMbrave150
- Status last verified
- Sep 2023
- First submitted
- 31 Jan 2018
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Xu XQ, Li WM, Shi LC, Wang H, Li S, Huang C, You H, Jia JD, He YW, Kong YY. Impact of temporary atezolizumab and bevacizumab interruption on survival in advanced HCC: an IMbrave150 analysis. Oncologist. 2025 Sep 1;30(9):oyaf269. doi: 10.1093/oncolo/oyaf269.
PubMed 40891895Gao Y, Cheng AL, Li LX, Parent N, Kichenadasse G, Karapetis CS, Rowland A, Hopkins AM, Sorich MJ. Evaluation of hyperprogressive disease with atezolizumab plus bevacizumab for hepatocellular carcinoma: A secondary analysis of the IMbrave150 trial. Int J Cancer. 2025 Jul 15;157(2):336-344. doi: 10.1002/ijc.35407. Epub 2025 Mar 13.
PubMed 40079683Kaseb 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.
PubMed 36254201Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.
PubMed 36111952Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11.
PubMed 34902530Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.
PubMed 34189869Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.
PubMed 34051880Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.
PubMed 33556230Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
PubMed 32402160
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03434379
- Acronym / sponsor ID
- IMbrave150 / YO40245
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Posted 5 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab + Bevacizumab | Experimental | Drug: Atezolizumab, Drug: BevacizumabParticipants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator |
| Sorafenib | Active comparator | Drug: SorafenibParticipants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAtezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle | Drug | Atezolizumab + Bevacizumab |
| BevacizumabBevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle | Drug | Atezolizumab + Bevacizumab |
| SorafenibSorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle | Drug | Sorafenib |
Primary outcome
Overall Survival (OS) in the Global Population
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)
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
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)
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
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)
OS was defined as the time from randomization to death from any cause.
PFS-IRF Per RECIST v1.1 in the China Population
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)
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).
35 secondary outcomes
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-IRF Per HCC mRECIST in the Global Population
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)
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
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)
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
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)
TTP-IRF Per HCC mRECIST in the Global Population
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)
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
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)
Overall Survival by Baseline AFP in the Global Population
Time frame: From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
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)
PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
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)
Time to Deterioration (TTD) in the Global Population
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)
Number of Participants With Adverse Events (AEs) in the Global Population
Time frame: Up to end of study (up to approximately 56 months)
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)
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)
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)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
Time frame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
PFS-IRF Per HCC mRECIST in the China Population
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)
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
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)
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
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)
TTP-IRF Per HCC mRECIST in the China Population
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)
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
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)
Time to Deterioration (TTD) in the China Population
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)
Number of Participants With Adverse Events (AEs) in the China Population
Time frame: Up to end of study (up to approximately 56 months)
Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
Time frame: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40891895Xu XQ, Li WM, Shi LC, Wang H, Li S, Huang C, You H, Jia JD, He YW, Kong YY. Impact of temporary atezolizumab and bevacizumab interruption on survival in advanced HCC: an IMbrave150 analysis. Oncologist. 2025 Sep 1;30(9):oyaf269. doi: 10.1093/oncolo/oyaf269.
- Derived from this study: PubMed 40079683Gao Y, Cheng AL, Li LX, Parent N, Kichenadasse G, Karapetis CS, Rowland A, Hopkins AM, Sorich MJ. Evaluation of hyperprogressive disease with atezolizumab plus bevacizumab for hepatocellular carcinoma: A secondary analysis of the IMbrave150 trial. Int J Cancer. 2025 Jul 15;157(2):336-344. doi: 10.1002/ijc.35407. Epub 2025 Mar 13.
- Derived from this study: PubMed 36254201Kaseb 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.
- Derived from this study: PubMed 36111952Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.
- Derived from this study: PubMed 34902530Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11.
- Derived from this study: PubMed 34189869Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.
- Derived from this study: PubMed 34051880Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.
- Derived from this study: PubMed 33556230Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.
- Derived from this study: PubMed 32402160Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Carcinoma, Hepatocellular
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
119 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atezolizumab, Bevacizumab and Sorafenib in people with Carcinoma, Hepatocellular, run by Hoffmann-La Roche at 119 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States, China, Japan, France, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) in the Global Population (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434379, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.