Actively Recruiting
Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-20
21
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older at the time of consent.
- Must understand and voluntarily sign informed consent before any study procedures.
- Must be able and willing to follow the study visit schedule and protocol requirements.
- Must have enough archived tumor tissue for PD-L1 CPS testing, or agree to a fresh tumor biopsy if needed.
- For oropharynx cancer, p16/HPV status must be determined; cell free HPV DNA testing is also acceptable.
- Must have surgically removable head and neck squamous cell carcinoma (oral cavity, oropharynx, larynx, hypopharynx).
- Patients with p16-positive or HPV-positive unknown primary head and neck cancer are eligible.
- Must be newly diagnosed with T1-2 N1-3 or T3-4 N0-3 disease and scheduled for surgery as standard care.
- Must have an ECOG performance status of 0 or 1.
- Must meet the laboratory criteria outlined in the protocol.
- Patients of childbearing potential and their partners must agree to use effective birth control starting from consent and for 1 year after treatment.
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment.
You will not qualify if you...
- Active autoimmune disease requiring systemic treatment in the past 2 years.
- History of non-infectious pneumonitis requiring steroids or current pneumonitis.
- Allergic reactions to cetuximab or similar compounds, or history of red meat allergy/tick bite.
- Active infection requiring systemic therapy.
- Known HIV infection.
- Known or active Hepatitis B or active Hepatitis C infection.
- History of left ventricular ejection fraction below 45% or New York Heart Association Class 2 or higher.
- Uncontrolled hypertension above 160/90 mmHg confirmed by repeat measurement.
- History of severe heart rhythm problems or significant ECG abnormalities.
- Symptomatic heart failure, unstable angina, recent heart attack, or severe cardiovascular disease.
- Pregnant, breastfeeding, or parturient women.
- Patients legally unable to consent or hospitalized without consent due to judicial or administrative decision.
- Patients in emergency situations unable to consent to the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
K
Kaleigh Tanner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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