Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

STATUS

Recruiting
participants needed

30
sponsor

Wake Forest University Health Sciences

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Updated on 19 February 2024

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cancer

measurable disease

squamous cell carcinoma of head and neck

squamous cell carcinoma

carcinoma

cetuximab

pd-1 inhibitor

head and neck cancer

metastatic squamous cell carcinoma

metastatic head and neck squamous cell carcinoma

cancer of the head

metastatic head and neck squamous cell cancer

recurrent head and neck squamous cell carcinoma

Summary

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This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.

Description

Primary Objective:

To measure Overall Response Rate to treatment with Cetuximab as single agent following treatment with immunotherapy with PD-1 inhibitors alone or in combination with chemotherapy.

Secondary Objective(s):

Measure Duration of Response (DUR), Progression Free Survival and Overall Survival and for treatment with single agent Cetuximab after immunotherapy with PD-1 inhibitors in Head and Neck Squamous Cell Carcinoma.
Evaluate treatment toxicity with single agent Cetuximab in this patient population.

Exploratory Objectives:

I. Evaluate the early positron emission tomography (PET) scan ability to predict tumor response.

II. Collect quality of life (QOL) data on patient reported outcomes every six weeks and examine this data for overall tolerability of this treatment.

III. Bank saliva and blood for future studies of biomarkers. IV. Correlate treatment response with human papillomavirus (HPV) and smoking status.

OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 week and then every 6-8 weeks thereafter.

Details

Condition	Recurrent Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma
Age	18years - 100years
Treatment	Questionnaire Administration, Cetuximab, Quality of life assessment
Clinical Study Identifier	NCT04375384
Sponsor	Wake Forest University Health Sciences
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma including cutaneous squamous cell cancer of the head and neck
	Measurable disease by scans- at least one measurable lesion
	Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy in the last 6 months
	Patients must have a Performance Status of 0-2
	Patients must be greater than or equal to 18 years old
	Willing to provide consent for collection of samples of blood and saliva as scheduled through the treatment
	Subject is willing and able to comply with the protocol for the duration of the study
	Willingness to donate 2 tablespoons of blood and one teaspoon of saliva before treatment, 4 times during the first 6 weeks of treatment and then every 6-8 weeks while patients is under treatment
	Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document
Exclusion Criteria
	Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway
	Prior allergic reaction to Cetuximab
	History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab
	Patients receiving any other investigational agents
	Patient is on medications that need to be continued and that might interact with Cetuximab
	Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures
	Subject with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan
	Any of the following conditions: Serious or non-healing wound, ulcer, or bone fracture, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment, history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment, history of myocardial infarction, ventricular arrhythmia, stable/unstable angina, -symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment, history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within 6 months of study enrollment, any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids
	Pregnancy, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment

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recurrent head and neck squamous cell carcinoma

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Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer