RecruitingNot Applicable

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

Italy25 participantsStarted 2024-11-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT07448727

SponsorUniversity of Rome Tor Vergata

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Vincenzo Formica, Professor

+390620908190 vincenzo.formica@uniroma2.it

View on ClinicalTrials.gov More Head & Neck Cancer trials