Study of Cetuximab Treatment After Immunotherapy Failure in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are studying the use of Cetuximab as a single treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma who have not responded to or cannot tolerate immunotherapy with PD-1 inhibitors, alone or combined with chemotherapy. This Phase II trial aims to evaluate the overall response rate to Cetuximab, along with progression-free survival, overall survival, duration of response, and treatment toxicity in this patient population. Participants receive an initial loading dose of Cetuximab intravenously over 2 hours followed by a 1-hour observation. Subsequent weekly maintenance doses are given intravenously over 1 hour without further observation. Treatment continues weekly unless the disease progresses or unacceptable side effects occur. After treatment ends, patients are monitored with follow-up visits at 1 week and then every 6 to 8 weeks for up to approximately 2 years. During the trial, participants undergo regular scans to measure tumor response before treatment, at 7 weeks, and then every 6 to 8 weeks during treatment. Researchers also collect data on survival times and treatment side effects using standardized criteria. Additional assessments include quality of life questionnaires. The total participation duration may extend up to about 2 years, including treatment and follow-up periods.

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