RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-02-20

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06855212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 is required. * If the primary site is oropharynx, p16/HPV status must be determined. HPV status determined by cell free HPV DNA testing is also acceptable. * Must have surgically resectable HNSCC including oral cavity, oropharynx, larynx, and hypopharynx. Patients with p16-positive or HPV-positive unknown primary of head and neck are eligible. Must be newly diagnosed HNSCC with T1-2 N1-3 or T3-4 N0-3 undergoing surgery as a standard of care. If the tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, skull base or encases carotid artery, and/or prevertebral fascia involvement, it will be considered as unresectable and excluded. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Must meet the laboratory criteria outlined in the protocol. * Patients of childbearing potential and patients whose sexual partners are of childbearing potential must be willing to practice an approved method of highly effective birth control with their partners starting at the time of informed consent and for 1 year after the completion of the study treatment regimen. Women of childbearing potential must have a negative pregnancy test within the 7 days prior to enrollment.	* Patients with an active autoimmune disease that has required systemic treatment in past 2 years. * Patients with a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Patient with a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or if the patient had red meat allergy/tick bite history. * Patients with an active infection requiring systemic therapy. * Patients with a known history of human immunodeficiency virus (HIV) infection. * Patients with a known history of or is positive for Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \[HCV\] ribonucleic acid is detected). * Patients who have a history of a left ventricular ejection fraction (LVEF) of \< 45% or who are New York Heart Association (NYHA) Class 2 or higher. * Patients with cardiovascular disease defined as: Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted). History of torsades de pointes, significant electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT (QTc) \> 450 msec (for men) or \> 470 msec (for women). Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction \< 20%, transient ischemic attack, or cerebrovascular accident within 12 months of Day 1). * Patients who are of the following protected classes will be excluded: Pregnant, parturient, or breastfeeding women. Persons who are hospitalized without consent because of a judiciary or administrative decision. Patients with a legal protection measure or a person who cannot express his/her consent. Patients in emergency situations who cannot consent to the study.

Inclusion Criteria

Exclusion 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 is required.
* If the primary site is oropharynx, p16/HPV status must be determined. HPV status determined by cell free HPV DNA testing is also acceptable.
* Must have surgically resectable HNSCC including oral cavity, oropharynx, larynx, and hypopharynx. Patients with p16-positive or HPV-positive unknown primary of head and neck are eligible. Must be newly diagnosed HNSCC with T1-2 N1-3 or T3-4 N0-3 undergoing surgery as a standard of care. If the tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, skull base or encases carotid artery, and/or prevertebral fascia involvement, it will be considered as unresectable and excluded.
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Must meet the laboratory criteria outlined in the protocol.
* Patients of childbearing potential and patients whose sexual partners are of childbearing potential must be willing to practice an approved method of highly effective birth control with their partners starting at the time of informed consent and for 1 year after the completion of the study treatment regimen. Women of childbearing potential must have a negative pregnancy test within the 7 days prior to enrollment.

* Patients with an active autoimmune disease that has required systemic treatment in past 2 years.
* Patients with a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
* Patient with a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or if the patient had red meat allergy/tick bite history.
* Patients with an active infection requiring systemic therapy.
* Patients with a known history of human immunodeficiency virus (HIV) infection.
* Patients with a known history of or is positive for Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \[HCV\] ribonucleic acid is detected).
* Patients who have a history of a left ventricular ejection fraction (LVEF) of \< 45% or who are New York Heart Association (NYHA) Class 2 or higher.
* Patients with cardiovascular disease defined as: Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted). History of torsades de pointes, significant electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT (QTc) \> 450 msec (for men) or \> 470 msec (for women). Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction \< 20%, transient ischemic attack, or cerebrovascular accident within 12 months of Day 1).
* Patients who are of the following protected classes will be excluded: Pregnant, parturient, or breastfeeding women. Persons who are hospitalized without consent because of a judiciary or administrative decision. Patients with a legal protection measure or a person who cannot express his/her consent. Patients in emergency situations who cannot consent to the study.

Contacts and Locations

Study Contact

Kara Hoffman

CONTACT

813-745-6020

kara.hoffman@moffitt.org

Principal Investigator

Christine Chung

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Christine Chung, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-20

Study Completion Date2028-03

Study Record Updates

Study Start Date2025-02-20

Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma