At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed head and neck squamous cell carcinoma
- ✓Measurable disease by scans with at least one measurable lesion
- ✓Prior treatment with PD-1 inhibitor alone or in combination with chemotherapy
- ✓Age at least 18 years old
- ✕Prior cetuximab or EGFR pathway-targeting therapy within 5 years
- ✕Prior allergic reaction to cetuximab
- ✕History of allergic reactions to compounds similar to cetuximab
- ✕Currently receiving other investigational agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Cetuximab, Questionnaire administration, and 1 other intervention for Head and Neck Squamous Cell Carcinoma and 2 related conditions. Currently recruiting, targeting 38 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
Ancillary studies
Ancillary studies