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Clinical Trial Protocol

JAVELIN Head and Neck 100: a Phase III trial of avelumab and chemoradiation for locally advanced head and neck cancer

    Yao Yu

    Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

    &
    Nancy Y Lee

    *Author for correspondence:

    E-mail Address: leen2@mskcc.org

    Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

    Published Online:https://doi.org/10.2217/fon-2018-0405

    Chemoradiotherapy (CRT) is the standard of care for locoregionally advanced squamous cell carcinomas of the head and neck (HNSCC). The immune checkpoint inhibitors nivolumab and pembrolizumab were recently approved by the US FDA for treatment of recurrent or metastatic HNSCC that are refractory to platinum chemotherapy. However, prospective studies incorporating immune checkpoint inhibitors in the definitive management of poor prognosis, nonmetastatic, locoregionally advanced HNSCC are lacking. The JAVELIN Head and Neck 100 study is a multinational, Phase III, double-blind, placebo-controlled, randomized clinical trial assessing the efficacy of avelumab, a PD-L1 inhibitor, in combination with CRT compared with placebo in combination with CRT for high-risk HNSCC.

    Trial registration: Javelin Head and Neck 100; NCT 02952586.

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

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