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Prospective Observational Study On The Impact Of Early Response To First-line Anti-PD-1 Therapy In Patients With Recurrent And/Or Metastatic (R/M) Head And Neck Squamous Cell Carcinoma, Assessed By 18F-FDG PET/CT (PEMBRO-PET)
This study aims to evaluate the role of early response assessment by 18F-FDG PET/CT in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma with PD-L1 CPS \>1 treated with pembrolizumab monotherapy, in accordance with routine clinical practice.
Details
| Lead sponsor | University of Rome Tor Vergata |
|---|---|
| Status | RECRUITING |
| Enrolment | 25 |
| Start date | 2024-11-20 |
| Completion | 2027-12 |
Conditions
- Head & Neck Cancer
- Head & Neck Squamous Cell Carcinoma
Primary outcomes
- Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab — through study completion, an average of 1 year
To evaluate whether changes in metabolic activity on 18F-FDG PET/CT at 6 weeks predict response to pembrolizumab monotherapy at 3, 6, and 9 months in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC).
Countries
Italy