Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head & Neck Cancer | — | UNRESOLVED | — |
| Head & Neck Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Predictive value of 18F-FDG PET/CT metabolic changes at 6 weeks for response to pembrolizumab
- timeFrame
- through study completion, an average of 1 year
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available