Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
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- STATUS
- Recruiting
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- participants needed
- 30
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- sponsor
- Wake Forest University Health Sciences
Summary
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 | 18-100 years |
| 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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