Dana-Farber Cancer Institute
This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). The names of the study drugs used in this research study are: * ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein) * pembrolizumab (a type of monoclonal antibody)
This open-label, non-randomized, phase 2 clinical trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck. The U.S. Food and Drug Administration (FDA) has not approved ficerafusp alfa as treatment for resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck. The FDA has approved pembrolizumab as treatment for resectable, high-risk, locoregionally…
Inclusion Criteria: * Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SCC), larynx, or hypopharynx. * Participants should have resectable disease at baseline per the discretion of the treating surgical oncologist. * Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the Ameri…
Bifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.
Monoclonal antibody, single-dose vial, via intravenous infusion per protocol.
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