Locally Recurrent OCSCC Clinical Trial
Official title:
A Phase 2 Study to Evaluate the Efficacy of the Combination of Cemiplimab and Cetuximab Prior to Salvage Surgery in Patients With Locally Recurrent (Stage 3-5) OCSCC
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent OCSCC.
Primary Objective: - To assess the efficacy of cemiplimab and cetuximab in patients with recurrent OCSCC Secondary Objective: - To assess safety of cemiplimab and cetuximab prior salvage surgery - To evaluate the efficacy of cemiplimab and cetuximab prior salvage surgery on measures - To estimate the one-year disease free survival (DFS) - To estimate the median overall survival (OS) Tertiary/Exploratory Objective: - To explore patient-reported outcomes (PRO) during CC and following salvage surgical resection - Assess impact of cemiplimab and cetuximab on surgery and adjuvant therapy - To explore biomarkers that may predict response to therapy ;