Actively Recruiting
Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma
Led by University of Cincinnati · Updated on 2026-04-15
40
Participants Needed
1
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the Phase I study is to see if it is safe to use X-ray photon radiation (XRT) and proton radiation (PT) before surgery in patients with recurrent head and neck squamous cell carcinoma (rHNSCC). The purpose of the Phase II study is to see if using XRT or PT before immunotherapy (pembrolizumab) prior to surgery benefits patients with recurrent head and neck squamous cell carcinoma (rHNSCC).
CONDITIONS
Official Title
Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed recurrent head and neck squamous cell carcinoma (oral cavity, laryngeal, hypopharyngeal, or oropharyngeal HPV-negative)
- Candidates for salvage surgical resection
- Previous radiation therapy completed more than 6 months ago with at least 30 Gy to target area
- Disease limited to a single or adjacent sites treatable in one area, tumor size less than 7 cm
- PD-L1 combined positive score (CPS) of 1% or higher
- Age 18 years or older
- ECOG performance status 0 or 1 (or Karnofsky 70% or higher)
- Adequate organ and marrow function (platelets ≥100,000/mcL, bilirubin ≤ institutional limit, AST/ALT ≤3 times limit, creatinine ≤1.5 times limit or GFR ≥30 mL/min/1.73 m2)
- Available archival tumor tissue for baseline analysis
- HIV-positive patients on effective therapy with undetectable viral load in past 6 months eligible
- Patients with controlled hepatitis B or treated hepatitis C eligible
- Previous or current other cancers allowed if they do not interfere with study
- Patients with cardiac risk class 2B or better by NYHA classification
- Women and men must agree to use contraception during study and for 4 months after pembrolizumab
- Ability to understand and sign informed consent
You will not qualify if you...
- Patients with metastatic disease
- Ongoing adverse effects from prior cancer therapy that prevent completing study treatment
- Receiving other investigational agents currently
- Prior PD-1 inhibitor treatment within last 6 months or progression on PD-1 inhibitor
- Autoimmune or pro-inflammatory diseases except stable asthma, minor allergies, vitiligo, or hypothyroidism
- Active steroid use over 10 mg prednisone daily except non-systemic forms
- Uncontrolled illness or conditions making participation unsafe
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
U
UCCC Clinical Trials Office
CONTACT
T
Trisha Wise-Draper, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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