NCT07448727

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
18mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Nov 2024Dec 2027

Study Start

First participant enrolled

November 20, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 4, 2026

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

February 12, 2026

Last Update Submit

February 28, 2026

Conditions

Head & Neck CancerHead & Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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).

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Any controindication to immune checkpoint inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tor Vergata University Hospital

Rome, Italy, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Vincenzo Formica, Professor

CONTACT

+390620908190vincenzo.formica@uniroma2.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2026

First Posted

March 4, 2026

Study Start

November 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 4, 2026

Record last verified: 2025-12

Locations

IT(1)