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RECRUITING
NCT04375384
PHASE2

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

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

Questionnaire administration

Ancillary studies

OTHER

Quality of life assessment

Ancillary studies

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States