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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07448727

Acronym

PEMBRO-PET

Enrollment

Registered

2026-03-04

Start date

2024-11-20

Completion date

2027-12-01

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma

Brief 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.

Detailed description

Eligible patients will receive two administrations of Pembrolizumab as monotherapy. An 18F-FDG PET/CT scan will be performed at baseline (T0; no more than 30 days before the first drug administration) and after two cycles (T1, at 6 weeks). Patients will be considered responders if they achieve a complete response (defined as complete resolution of FDG uptake within the target lesions) or a partial response (i.e., \>=30% decrease in the target tumor FDG SULpeak). After the first two administrations of Pembrolizumab, as well as in case of progressive disease (i.e., \>=30% increase in the target tumor FDG SULpeak or advent of new 18FDG-avid lesions), any treatment modification will be determined by the physician according to routine clinical practice

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Italy

Contacts

CONTACTVincenzo Formica, Professor

vincenzo.formica@uniroma2.it+390620908190

Outcome results