M.D. Anderson Cancer Center
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.
Primary Objective: \- Primary Objectives To evaluate the clinical efficacy, defined as overall response rate, of cemiplimab combined with cetuximab in patients with recurrent oral cavity and HPV-negative oropharynx squamous cell carcinoma. Secondary Objective: -To evaluate other markers of clinical efficacy (pathological response rates, objective response rate per RECIST, overall survival) and safety. Exploratory Endpoints * To explore patient-reported outcomes (PRO) during CC and following salvage surgical resection * Assess impact of cemiplimab and cetuximab on surgery and adjuvant ther…
Inclusion Criteria: 1. Subjects .18 years with histology-proven locoregionally recurrent oral cavity squamous cell carcinoma or HPV-negative OPSCC 2. HPV testing is required only in oropharyngeal sites and must be negative 3. Amenable to salvage surgery 4. 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). 5. Measurable disease per RECIST 1.1 6. Performance statu…
Given by IV
Given by IV
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