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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Rome Tor Vergata
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab
Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Vincenzo Formica
Professor
University of Rome Tor Vergata