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.
Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.
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.
Patients must have a Performance Status of 0-2.
Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) years.
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.
Single group
Cetuximab
DrugA loading dose of Cetuximab will be administered intravenously in the first day of treatment. The dose is 400 mg/m2 and will be infused over 2h followed by 1h observation. The maintenance dose of Cetuximab is 250 mg/m2 and will be infused over 1h. No further observation time needed. The maintenance dose of cetuximab will be given every 7 days (+/- 2 days) starting 7 days (+/- 2 days) after the loading dose of cetuximab. Pre-medicate with 50 mg Diphenhydramine IV before the loading dose of Cetuximab and as per standard of care before the maintenance treatment.
Questionnaire administration
Other interventionAncillary studies
Quality of life assessment
Other interventionAncillary studies
Change in Overall Response Rate To Treatment with Cetuximab
Overall response rate is defined as the proportion patients achieving partial response or complete response per RECIST v1.1 criteria. An estimate of a 95% Exact Clopper Pearson confidence interval will be used. RECIST 1.1 criteria will be used to measure tumor size: Measurable disease is defined by the presence of at least 1 measurable lesion. A lesion, not previously irradiated per the protocol prior to enrollment, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and that is suitable for accurate repeated measurements. Non-measurable: All other lesions, including small lesions (longest diameter \<10 mm or pathological lymph nodes with ≥10 mm to \<15 mm short axis at baseline). Only participants with measurable disease at baseline will be included in the study.
Duration of Progression Free Survival
Progression free survival will be defined as progression of local-regional disease, distant metastases or death without progression and will be reported as median progression-free survival as well as progression free survival at 6 month and 1 year time points. Investigators will estimate Kaplan Meier survival curves and estimate the median duration of response with 95% confidence intervals for these measures.
Duration of Overall Survival
Overall survival is defined as death due to any cause and will be reported as median overall survival as well as overall survival at 6 month and 1 year time points. Investigators will estimate Kaplan Meier survival curves and estimate the median duration of response with 95% confidence intervals for these measures.
Duration of Response
Response is defined as (failure - progression of loco-regional disease or distant metastasis) Investigators will estimate Kaplan Meier survival curves and estimate the median duration of response and will also estimate 95% confidence intervals for this measure.
Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Treatment-related side effects will be collected before each treatment based on clinical laboratory and radiologic changes and will be graded and reported. All patients who receive at least one dose of cetuximab will be considered evaluable for safety analysis. Investigators will create frequency tables that count the number and severity of toxicities observed in this study.
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Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator
