Spots Global Cancer Trial Database for Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

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Trial Identification

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

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

Study ID: NCT04375384

Conditions

Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Metastatic Head-and-neck Squamous-cell Carcinoma

Interventions

Cetuximab

Questionnaire administration

Quality of life assessment

Study Description

Brief 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.

Detailed 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.