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

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Primary Objective: • To measure Overall Response Rate to treatment with Cetuximab as single agent in patients with recurrent or metastatic head and neck squamous cell cancer who failed 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. 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. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Squamous Cell Carcinoma
  • Metastatic Head-and-neck Squamous-cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT04375384
Study type Interventional
Source Wake Forest University Health Sciences
Contact Study Nurse
Phone 336-713-7748
Email saverill@wakehealth.edu
Status Recruiting
Phase Phase 2
Start date July 1, 2020
Completion date January 2025
View Details
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