A Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for Head and Neck Squamous Cell Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of the study is to determine if cemiplimab in combination with cetuximab given before their surgery are beneficial and safe in participants with head and neck squamous cell carcinoma (HNSCC).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must be ≥ 18 years of age at the time of consent. * Patient (or a legally authorized representative) must understand and voluntarily sign informed consent prior to any study-related assessments/procedures being conducted. * Must be able and willing to comply to the study visit schedule and protocol requirements. * Must have sufficient archived tumor tissue available for PD-L1 CPS determination. If not, patient must agree to a fresh tumor biopsy before starting the treatments. If patient only had a fine needle aspiration, a fresh biopsy with a core needle or punch biopsy…
Interventions
- DrugCemiplimab
Given by IV infusion.
- DrugCetuximab
Given by IV infusion.
Location
- Moffitt Cancer CenterTampa, Florida