NCT04375384

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Metastatic Head-and-neck Squamous-cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2020-05-05
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study