Actively Recruiting
Study of Cemiplimab and Cetuximab Before Salvage Surgery in Adults With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-07-30
17
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying whether giving cemiplimab and cetuximab before salvage surgery can help control recurrent oral cavity squamous cell carcinoma and HPV-negative oropharyngeal squamous cell carcinoma. This phase 2 trial aims to evaluate the clinical effectiveness, including overall response rate, safety, and other outcomes like pathological response and survival. The trial also explores patient-reported outcomes and biomarkers related to treatment response. Participants will receive cemiplimab and cetuximab together intravenously for 6 weeks before undergoing salvage surgery. After surgery, depending on tumor response, participants may receive cemiplimab alone for up to one year. The study focuses on how these treatments affect surgery outcomes and the need for additional therapy. During the study, participants will have biopsies, laboratory tests, and clinical assessments to monitor response and safety. Researchers will track adverse events for about one year and collect patient feedback on treatment effects. The total participation spans from initial treatment through surgery and follow-up therapy, including monitoring overall survival and treatment tolerability.
CONDITIONS
Brief Title
Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma
Research Team
L
Luana Guimaraes De Sousa, MD
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