Study of Early Response to Pembrolizumab Treatment in Adults With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Using 18F-FDG PETCT

What this Trial Is About

This research aims to evaluate the role of early response assessment using 18F-FDG PETCT scans in patients with recurrent or metastatic head and neck squamous cell carcinoma who have a PD-L1 Combined Positive Score greater than 1 and are treated with pembrolizumab monotherapy. The study focuses on understanding how early metabolic changes detected by PETCT can predict response to this first-line immunotherapy in routine clinical practice. Eligible patients will receive two doses of pembrolizumab as their sole treatment. PETCT scans will be done at the start of treatment and again after six weeks, following two cycles of pembrolizumab. Responses will be measured by looking for complete disappearance or at least a 30% decrease in tumor metabolic activity. Treatment changes after these two cycles or if disease progression occurs will be decided by the treating physician according to standard care. Participants will undergo PETCT imaging before treatment and after six weeks to assess tumor response. Researchers will monitor metabolic changes to predict outcomes during an average follow-up of one year. This observational study includes regular clinical assessments but does not involve experimental treatment assignments. The goal is to understand early indicators of pembrolizumab response to guide treatment decisions in patients with advanced head and neck cancer.

Impact of Early Response to First-line Anti-PD-1 Monotherapy in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma, Assessed by 18F-FDG PET/CT