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

Inclusion Criteria2

  • Histological diagnosis of recurrent and/or metastatic HNSCC, not amenable for curative locoregional treatment (either surgery or radiotherapy), and amenable for first line systemic treatment
  • CPS PD-L1 \>=1

Exclusion Criteria1

  • Any controindication to immune checkpoint inhibitors

Locations(1)

Tor Vergata University Hospital

Rome, Italy, Italy

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NCT07448727


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