Early PET/CT response after first‑line pembrolizumab in recurrent or metastatic head and neck cancer
Official title: 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
Run by University of Rome Tor Vergata · NCT07448727 · Data updated 2026-11-12
This project will see if an 18F‑FDG PET/CT scan after two doses of pembrolizumab can tell who is responding among patients with recurrent or metastatic PD‑L1 CPS ≥1 head and neck cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Drugs / interventions | pembrolizumab |
| Locations | 1 site (Rome, Italy) |
| Status | Recruiting |
| Started | November 20, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07448727 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with histologically confirmed recurrent or metastatic HNSCC not amenable to curative local therapy, eligible for first‑line pembrolizumab monotherapy, and with PD‑L1 CPS ≥1 who can undergo PET/CT imaging.
✕Probably not a fit
Patients with PD‑L1 CPS <1, contraindications to immune checkpoint inhibitors, or those unable to have the required PET/CT scans are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows patients with recurrent or metastatic head and neck squamous cell carcinoma and PD‑L1 CPS ≥1 who receive two administrations of pembrolizumab as first‑line monotherapy. An 18F‑FDG PET/CT is done at baseline (within 30 days before treatment) and again after two cycles (about 6 weeks) to measure changes in tumor FDG uptake. Responders are defined as complete resolution of FDG uptake in target lesions or a ≥30% decrease in target tumor FDG SULpeak, while progressive disease is a ≥30% increase in SULpeak or new FDG‑avid lesions. Any subsequent treatment changes are made by the treating physician according to routine clinical practice.
Why it matters
Potential benefit: If successful, the approach could identify responders early so clinicians can continue effective therapy or switch nonresponders sooner to other options.
How similar studies have gone: Prior small and exploratory studies have suggested that early PET/CT changes can correlate with immunotherapy outcomes, but findings are mixed and the approach is not yet standard practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Tor Vergata University Hospital
Rome, Italy, Italy Recruiting
Study contacts
- Study coordinator: Vincenzo Formica, Professor
- Email: vincenzo.formica@uniroma2.it
- Phone: +390620908190
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.