RecruitingPhase 2NCT06855212

Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC

A Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for Head and Neck Squamous Cell Carcinoma


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

21 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two immunotherapy drugs — cetuximab and cemiplimab — given before surgery for head and neck squamous cell cancer (HNSCC) to see whether they can shrink the tumor and help the immune system fight cancer more effectively. **You may be eligible if:** - You are 18 years or older - You have been newly diagnosed with resectable (surgically removable) head and neck cancer (oral cavity, throat, larynx, or hypopharynx) - Your cancer is stage T1-2 N1-3 or T3-4 N0-3 - You are in good health (ECOG performance status 0 or 1) - You are planning to have surgery as standard treatment - You have adequate tumor tissue available for testing **You may NOT be eligible if:** - You have an active autoimmune disease requiring systemic treatment - You have a history of severe pneumonitis (lung inflammation) requiring steroids - You are allergic to cetuximab or have had a tick bite or red meat allergy - You have HIV, active hepatitis B or C infection - You have significant heart disease or severely reduced heart function - You are pregnant, breastfeeding, or cannot consent to the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab

Given by IV infusion.

DRUGCetuximab

Given by IV infusion.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06855212


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