RecruitingPhase 2NCT04375384

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


Sponsor

Wake Forest University Health Sciences

Enrollment

38 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether cetuximab (a targeted antibody drug that blocks a growth signal called EGFR) can help people with head and neck cancer whose disease progressed after receiving immunotherapy. It is intended for patients who have already tried immune checkpoint therapy and need another option. **You may be eligible if...** - You are 18 or older - You have confirmed head and neck squamous cell cancer with measurable disease - You have already received immunotherapy (a PD-1 inhibitor), either alone or with chemotherapy - You are in generally good health (performance status 0-2) - You are willing and able to follow the study schedule **You may NOT be eligible if...** - You have previously been treated with cetuximab or any other drug targeting EGFR in the last 5 years - You had an allergic reaction to cetuximab - You have interstitial lung disease (lung scarring or inflammation) - You have had a stroke, heart attack, or blood clot in the past 6-12 months - You have a serious or non-healing wound or bone fracture - You are currently on immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT04375384


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