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
Wake Forest University Health Sciences
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.
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 ce…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma. * Measurable disease by scans- at least one measurable lesion. * Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy. * Patients must have a Performance Status of 0-2. * Patients must be greater than or equal to 18 years old. * Participant is willing and able to comply with the protocol for the duration of the study. * Ability to understand and the willingness to sign an Institutional Review Board-…
Interventions
- DrugCetuximab
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.
- OtherQuestionnaire administration
Ancillary studies
- OtherQuality of life assessment
Ancillary studies
Location
- Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina