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Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
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.
Official title: Pilot Phase II Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2020-07-01
Completion Date
2027-12
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Cetuximab
A 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
Ancillary studies
Quality of life assessment
Ancillary studies
Locations (1)
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States