MO42541 | IMbrave 251

OC Oncoclínicas SP

Gastrointestinal

A study of atezolizumab with lenvatinib or sorafenib versus lenvatinib or sorafenib alone in hepatocellular carcinoma previously treated with atezolizumab and bevacizumab (IMbrave251)

Center

OC Oncoclínicas SP

Principal investigator

Renata D´Alpino

Email

pesquisaclinicasp@oncoclinicas.com

Telephone

(11) 97144-5373

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 after prior combined atezolizumab plus bevacizumab treatment for HCC, for at least 4 consecutive treatment cycles and 2 subsequent tumor assessments. At least 1 tumor assessment must show stable disease (SD), partial response (PR) or complete response (CR);
At least one measurable target lesion (per RECIST v1.1) that has not previously been treated with local therapy or, if the target lesion is within the scope of prior local therapy, has subsequently progressed as per RECIST v1.1;
Eastern Cooperative Oncology Group (ECOG PS) performance status of 0 or 1 within 7 days prior to randomization
Child-Pugh Class A within 7 days prior to randomization.

Exclusion criteria

Symptomatic central nervous system (CNS) metastases, untreated or in active progression;
History of leptomeningeal disease;
History of hepatic encephalopathy, prior to 6 months, unresponsive to therapy within 3 days;
Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC;
History of non-HCC malignancy in the 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death.

Coordinator(s)

Mayara Batista
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