A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
NCT ID: NCT03434379
Last Updated: 2023-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
558 participants
INTERVENTIONAL
2018-03-15
2022-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab + Bevacizumab
Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator
Atezolizumab
Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
Bevacizumab
Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
Sorafenib
Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator
Sorafenib
Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
Interventions
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Atezolizumab
Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
Bevacizumab
Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
Sorafenib
Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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St. Josephs Hospital and Medical Center
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Uni of California - San Diego; Cancer Center & Dept of Medicine
La Jolla, California, United States
Kaiser Permanente Northern California
Novato, California, United States
University of California Irvine Medical Center
Orange, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, United States
University of California Los Angeles
Santa Monica, California, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
M.D Anderson Cancer Center; Uni of Texas At Houston
Houston, Texas, United States
Swedish Cancer Inst.
Seattle, Washington, United States
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Peking Union Medical College Hospital
Beijing, , China
Beijing Friendship Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
the First Hospital of Jilin University
Changchun, , China
Jilin Cancer Hospital
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
The First People's Hospital of Foshan; Local Ethic Committee
Foshan, , China
The 900th Hospital of PLA joint service support force
Fuzhou, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital
Hangzhou, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Anhui Province Cancer Hospital
Hefei, , China
General Hospital of Jinan Military Command of PLA
Jinan, , China
The 81st Hospital of P.L.A.
Nanjing, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, , China
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, , Czechia
Hopital Claude Huriez;Gastro Enterologie
Lille, , France
Hopital De La Croix Rousse; Hepatologie Gastro Enterologie
Lyon, , France
Hopital Timone Adultes; Gastro Enterologie
Marseille, , France
Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie
Montpellier, , France
Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie
Nantes, , France
CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie
Nice, , France
Hopital Charles Nicolle; Gastroenterologie
Rouen, , France
Hopital Hautepierre; Gastro Enterologie
Strasbourg, , France
Hôpital d'Adultes; Service hépato-gastro-entérologie
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy; Gastro-Enterologie
Villejuif, , France
Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie
Berlin, , Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt, , Germany
Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie
Hamburg, , Germany
Med. Hochschule Hannover; Gastroenterologie
Hanover, , Germany
Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.
Leipzig, , Germany
Uniklinik Mainz; I. Medizinische Klinik
Mainz, , Germany
Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
Regensburg, , Germany
Queen Mary Hospital; Dept. Of Haematology & Oncology
Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, , Hong Kong
Az. Osp. Rummo; Oncologia Medica
Benevento, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy
Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica
Orbassano, Piedmont, Italy
A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
Cagliari, Sardinia, Italy
Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico
Pisa, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padua, Veneto, Italy
Chiba University Hospital
Chiba, , Japan
National Cancer Center Hospital East
Chiba, , Japan
Kurume University Hospital
Fukuoka, , Japan
Sapporo Kosei Genaral Hospital
Hokkaido, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Saga-ken Medical Centre Koseikan
Saga, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
Japanese Red Cross Musashino Hospital
Tokyo, , Japan
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, , Poland
ID Clinic
Mysłowice, , Poland
SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY
Olsztyn, , Poland
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
Warsaw, , Poland
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
Wroc?aw, , Poland
FSBI "National Medical Research Center of Oncology N.N. Blokhin?; Clinical Biotechnologies
Moscow, Moscow Oblast, Russia
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, Sankt-Peterburg, Russia
National Cancer Centre
Singapore, , Singapore
Tan Tock Seng Hospital; Oncology
Singapore, , Singapore
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, , Spain
Centro Integral Oncologico Clara Campal; Servicio de Oncología
Madrid, , Spain
Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
Zaragoza, , Spain
National Cheng Kung University Hospital; Oncology
Tainan City, , Taiwan
Chi-Mei Medical Centre; Hematology & Oncology
Tainan City, , Taiwan
Veterans General Hospital; Cancer Center
Taipei, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, , Taiwan
Chang Gung Memorial Hospital-Linkou; Dept of Oncology
Taoyuan, , Taiwan
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Royal Free Hospital; Dept of Oncology
London, , United Kingdom
King'S College Hospital
London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
Countries
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References
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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.
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.
Li 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.
Cheng 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.
Salem 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.
Galle 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.
Wen 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.
Finn 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003691-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
YO40245
Identifier Type: -
Identifier Source: org_study_id
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