To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.
Subjects .18 years with histology-proven locoregionally recurrent oral cavity squamous cell carcinoma or HPV-negative OPSCC
HPV testing is required only in oropharyngeal sites and must be negative
Amenable to salvage surgery
Disease recurrence at least 3 months after completion of curative-intent therapy, which must include at least surgery and post operatory radiation. Previous systemic therapy is the curative-setting is not required but allowed (e.g., neoadjuvant chemotherapy, concurrent chemotherapy).
Disease recurrence within 3 months after completion of definitive treatment (including surgery, post operatory, systemic therapy)
Distant metastatic disease (M1), visceral and/or distant nodal
Prior treatment with an t immune checkpoint inhibitor agent in the curative setting is allowed if over 1 year from the date of completion (last dose)
Subjects with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
M.D. Anderson Cancer Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator