NCT07448727

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Eligible patients will receive two administrations of Pembrolizumab as monotherapy. An 18F-FDG PET/CT scan will be performed at baseline (T0; no more than 30 days before the first drug administration) and after two cycles (T1, at 6 weeks). Patients will be considered responders if they achieve a complete response (defined as complete resolution of FDG uptake within the target lesions) or a partial response (i.e., \>=30% decrease in the target tumor FDG SULpeak). After the first two administrations of Pembrolizumab, as well as in case of progressive disease (i.e., \>=30% increase in the target tumor FDG SULpeak or advent of new 18FDG-avid lesions), any treatment modification will be determined by the physician according to routine clinical practice

Conditions

• Head & Neck Cancer
• Head & Neck Squamous Cell Carcinoma

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-12-31
• Completion: 2027-12-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: Italy