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Clinical Trial ProtocolOpen Accesscc iconby iconnc iconnd icon

Cabozantinib in combination with atezolizumab versus sorafenib in treatment-naive advanced hepatocellular carcinoma: COSMIC-312 Phase III study design

    Robin Kate Kelley

    *Author for correspondence: Tel.: 415 353 7065; Fax: 415 353 9959;

    E-mail Address: katie.kelley@ucsf.edu

    UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA 94143, USA

    , , ,
    Fawzi Benzaghou

    Ipsen Bioscience, Inc., Cambridge, MA, USA

    ,
    Thomas Yau

    University of Hong Kong, Hong Kong, China

    ,
    Ann-Lii Cheng

    National Taiwan University College of Medicine, Taipei, Taiwan

    &
    Lorenza Rimassa

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, Italy

    Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

    Published Online:https://doi.org/10.2217/fon-2020-0283

    Cabozantinib is an oral tyrosine kinase inhibitor that targets VEGFR, MET and the TAM (TYRO3, AXL, MER) family of kinase receptors. In addition to their role in tumor growth and angiogenesis, cabozantinib targets promote an immune-suppressive microenvironment. Cabozantinib is approved as single-agent therapy for patients with advanced hepatocellular carcinoma who received prior sorafenib. Owing to its antitumor and immunomodulatory properties, cabozantinib is being developed in combination with immune checkpoint inhibitors. Early studies of these combinations have shown promising antitumor activity and tolerability in patients with solid tumors. Here, we describe the rationale and design of COSMIC-312, a Phase III study evaluating the safety and efficacy of cabozantinib in combination with atezolizumab (anti–PD-L1 monoclonal antibody) versus sorafenib for treatment-naive patients with advanced hepatocellular carcinoma.

    ClinicalTrial.gov Registration: NCT03755791

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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