Phase II Study of Cetuximab and Cemiplimab Before Surgery for Head and Neck Cancer

Inclusion Criteria

• Must be 18 years or older.
• Must understand and sign a consent form before any study-related activities.
• Must be willing to follow the study schedule and requirements.
• Must have enough tumor tissue available for specific testing. If not, must agree to a new biopsy.
• If the cancer is in the oropharynx, HPV status must be determined.
• Must have a type of head and neck cancer that can be surgically removed, including cancers of the oral cavity, oropharynx, larynx, and hypopharynx.
• Must be newly diagnosed with specific stages of HNSCC and scheduled for surgery.
• Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must meet certain lab test criteria.
• Patients and their partners must agree to use effective birth control during the study and for one year after treatment. Women must have a negative pregnancy test before joining the study.

Exclusion Criteria

• Have an active autoimmune disease needing treatment in the past 2 years.
• Have a history of lung inflammation requiring steroids or current lung inflammation.
• Have allergies to similar drugs or a history of red meat allergy/tick bites.
• Have an active infection needing treatment.
• Have a known history of HIV.
• Have active Hepatitis B or C.
• Have a heart condition with a low ejection fraction or certain heart disease symptoms.
• Have uncontrolled high blood pressure or certain heart rhythm issues.
• Be pregnant, breastfeeding, or unable to give consent due to legal or medical reasons.