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

ConditionsHead & Neck Cancer Head & Neck Squamous Cell Carcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Rome Tor Vergata

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any controindication to immune checkpoint inhibitors

Trial population

recurrent and/or metastatic HNSCC candidate for ICI-based first-line treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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

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).

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rome Tor Vergata

Lead sponsor

Source ClinicalTrials.gov

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