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 (IMbrave251)

  • STATUS
    Recruiting
  • End date
    Feb 5, 2025
  • participants needed
    554
  • sponsor
    Hoffmann-La Roche
Updated on 16 October 2022

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.

Details
Condition Unresectable Hepatocellular Carcinoma
Treatment Sorafenib, Atezolizumab, Lenvatinib
Clinical Study IdentifierNCT04770896
SponsorHoffmann-La Roche
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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