Actively Recruiting
Prospective Observational Study on Early Response to First-line Anti-PD-1 Therapy in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Assessed by 18F-FDG PET/CT
Led by University of Rome Tor Vergata · Updated on 2026-03-04
25
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the role of early response assessment using 18F-FDG PET/CT 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 PET/CT can predict response to this first-line immunotherapy in routine clinical practice. Eligible patients will receive two doses of pembrolizumab as their sole treatment. PET/CT 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 PET/CT 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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma not suitable for curative surgery or radiotherapy
- Eligible for first-line systemic treatment
- PD-L1 Combined Positive Score (CPS) of 1 or higher
You will not qualify if you...
- Any contraindication to immune checkpoint inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive two administrations of pembrolizumab and undergo 18F-FDG PET/CT scans before treatment and after two cycles to assess response.
2 visits (in-person) for PET/CT scans plus 2 treatment administrations
Duration - Up to 1 year or more
Participants are observed for treatment response and possible disease progression with treatment modifications determined by their physician according to routine clinical practice.
Follow-up visits as determined by routine clinical practice
Trial Site Locations
Total: 1 location
1
Tor Vergata University Hospital
Rome, Italy, Italy, 00133
Actively Recruiting
Research Team
V
Vincenzo Formica, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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