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A clinical trial to compare atezolizumab plus lenvatinib or sorafenib with lenvatinib or sorafenib alone in people with advanced and/or inoperable HCC (after previous treatment with atezolizumab plus bevacizumab)
A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
- Cancer
- Hepatocellular Carcinoma (HCC)
- Unresectable Hepatocellular Carcinoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Recruiting
This trial runs in
Cities
- Adana
- Ankara
- Athens
- Barcelona
- bei-jing-shi
- Bengaluru
- Bern
- Birmingham
- Bologna
- Bonheiden
- Bordeaux
- Brasschaat
- brielles
- Bruxelles
- Bursa
- Cairo Governorate
- Calgary
- Cebu City
- Cefalù
- chang-sha-shi
- cheng-du-shi
- Chiba
- Córdoba
- Edmonton
- Esslingen am Neckar
- Firenze
- Frankfurt
- Gent
- Goyang-si
- guang-zhou-shi
- Haifa
- Hamilton
- Hannover
- Harbin
- he-fei-shi
- Hefei Shi
- Helsinki
- Himeji
- Hiroshima
- Innsbruck
- İstanbul
- İzmir
- Jinan
- Kashiwa
- Kifisia
- Krung Thep Maha Nakhon
- Kuala Lumpur
- Kurume
- Leuven
- Lille
- Ljubljana
- London
- Madrid
- Mainz
- makati
- Manchester
- Marseille
- Milano
- Minas Gerais
- Minato City
- Montpellier
- Moscow
- Moscow Oblast
- Moskva
- Mumbai
- Musashino
- nan-jing-shi
- Nantes
- Napoli
- Newcastle upon Tyne
- Nice
- Osakasayama
- Oxford
- Padova
- Padua
- Palma
- Pamplona
- Panagyurishte
- Paris
- Pasig
- Pessac
- Petah Tikva
- Pisa
- Plovdiv
- Providencia
- Putrajaya
- Región Metropolitana
- Rio de Janeiro
- Rio Grande do Sul
- Roeselare
- Roma
- Sabadell
- Saint Petersburg
- Salzburg
- San José
- sankt-poelten
- Santa Catarina
- Santiago de Compostela
- Seongnam-si
- Seoul
- shang-hai-shi
- shen-yang-shi
- Shimotsuke
- Sofia
- Suita
- São Paulo
- Tainan City
- Taipei City
- Tallinn
- Tampere
- Tartu
- Tel Aviv-Yafo
- Thessaloniki
- tian-jin-shi
- Torino
- Toronto
- Toulouse
- Toyoake
- Turku
- Tübingen
- Ulm
- València
- Vandœuvre-lès-Nancy
- Varna
- Villejuif
- Wien
- Wirral
- yudino
- Zagreb
- Zaragoza
- Zürich
- Échirolles
- 横浜市
Trial Identifier:
NCT04770896 MO42541
Trial Summary
This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04770896,MO42541
Trial Identifier
Atezolizumab, Lenvatinib, Sorafenib
Treatments
Unresectable Hepatocellular Carcinoma
Condition
Official Title
A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
- Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR).
- At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization
- Child-Pugh class A within 7 days prior to randomization
- Adequate hematologic and end-organ function
Exclusion Criteria
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- History of leptomeningeal disease
- History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- 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
For the latest version of this information please go to www.forpatients.roche.com