Early PET/CT response after first‑line pembrolizumab in recurrent or metastatic head and neck cancer
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
University of Rome Tor Vergata · NCT07448727
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 |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rome Tor Vergata (other) |
| Drugs / interventions | pembrolizumab |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT07448727 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome, Italy
- Tor Vergata University Hospital — Rome, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Vincenzo Formica, Professor
- Email: vincenzo.formica@uniroma2.it
- Phone: +390620908190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma