This protocol addresses patients with incurable, recurrent or metastatic oral cavity carcinoma in whom tumour and immune cells express PD-L1 at a combined positive score (CPS) of ≥1. The confirmed biomarker status shapes the first-line systemic treatment approach.
PD-L1 expression, assessed across both tumour and immune cells and expressed as a combined positive score, must be confirmed at ≥1 before the recommended first-line regimen can be applied. This threshold distinguishes the population that is eligible for this treatment strategy from those who are not.
In this PD-L1–positive population, first-line therapy is built around a PD-1 checkpoint inhibitor — used either as monotherapy or alongside chemotherapy depending on clinical circumstances. The full structured regimen, including combination selections, criteria for choosing between options, and subsequent management pathways after first-line progression, is detailed in the complete protocol.
The antibody pembrolizumab, which targets the PD-1 receptor, shall be used in patients with PD-L1-expressing tumor and immune cells (CPS ≥1) as first line monotherapy or in combination with platinum and 5-fluorouracil.
After failure of a platinum-containing first-line therapy with pembrolizumab, a second-line therapy with a taxane, possibly in combination with cetuximab, can be carried out.
After failure of first-line therapy with pembrolizumab as monotherapy, second-line therapy with platinum/5-FU and cetuximab can be given.
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