RecruitingNCT07448727

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


Sponsor

University of Rome Tor Vergata

Enrollment

25 participants

Start Date

Nov 20, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a special type of scan — called a PET/CT scan using a radioactive sugar — can predict early on which patients with advanced head and neck squamous cell carcinoma are responding to immunotherapy (anti-PD-1 treatment). If the scan can detect early response, doctors could potentially change treatment plans sooner for patients who are not responding. **You may be eligible if:** - You have been diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (cancer of the mouth, throat, larynx, or related structures) - Your cancer is not suitable for surgery or radiation to cure it - Your tumor tests positive for PD-L1 (a protein that predicts immunotherapy response), with a Combined Positive Score (CPS) of 1 or higher - You are about to start or have just started first-line immunotherapy with an anti-PD-1 drug **You may NOT be eligible if:** - You have any medical condition that prevents you from safely receiving immune checkpoint inhibitor therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Tor Vergata University Hospital

Rome, Italy, Italy

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NCT07448727


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