Clinical trial · Interventional
Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
A Pilot Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- 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 is a single-center cross-sectional imaging and correlative biomarker study in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment and Cohort 2 will be neoadjuvant study participants who will receive one dose of anti-PD-1 treatment prior to tumor resection or radiation. Blood sampling and tissue biopsies will be collected from both cohorts and both cohorts will undergo two whole body PET(Positron Emission Tomography)/CT(Computed Tomography) imaging with \[18F\]F-AraG. First scan prior to initiating anti-PD-1 treatment and second scan post initiation of anti-PD-1 treatment in Cohort 1 and prior to tumor resection or radiation in Cohort 2
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 Patients with M/R SCCHN
- description
- Patients with unresectable and metastatic SCCHN cancer who will receive anti-PD-1 treatment under SOC. SOC treatments currently include nivolumab and pembrolizumab ("anti-PD-1 treatment"). The protocol may be amended to include other agents should they become SOC. Patients will receive a baseline \[18F\]F-AraG PET/CT scan and another \[18F\]F-AraG PET/CT scan 6 to 12 weeks after anti-PD-1 dose.
- interventionNames
- Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
- type
- EXPERIMENTAL
- label
- Cohort 2 Patients with de novo SCCHN
- description
- Patients with de novo SCCHN prior to initiation of anti-cancer treatment (e.g., radiation, chemoradiation, or surgery). Patients will receive ONE DOSE of the anti-PD-1 treatment, after the baseline \[18F\]F-AraG PET/CT scan, baseline blood and tumor tissue collection. Patients will receive a second \[18F\]F-AraG PET/CT scan 2 - 3 weeks after the one dose of anti-PD-1 treatment.
- interventionNames
- Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable or metastatic SCCHN. * Localized SCCHN. * \>18 years old. * Willing and able to sign consent form. * Have standard of care biopsy or resection planned or tumors amenable to serial biopsies. * For patients with reproductive potential must undergo counseling to understand unknown risks to resultant progeny. Exclusion Criteria: * Diagnosis of immunodeficiency or active autoimmune condition. * Active tuberculosis * Prior exposure to PD-1 or PD-LI treatment * Prior systemic chemotherapy within 2 weeks of planed anti-PD1 treatment. * Received a live vaccine within 30 days of planned PD-1 start date. * Pregnant or breastfeeding.
References
Publications (0)
Data not yet available