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
Head & Neck CancerHead & Neck Squamous Cell Carcinoma
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Any controindication to immune checkpoint inhibitors
Primary outcome measure(s)
Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab — through study completion, an average of 1 year To evaluate whether changes in metabolic activity on 18F-FDG PET/CT at 6 weeks predict response to pembrolizumab monotherapy at 3, 6, and 9 months in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC).
Trial sites (1)
Facility
City
Region
Status
Tor Vergata University Hospital
Rome
Italy
Recruiting
More University of Rome Tor Vergata trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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