Actively Recruiting
Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-02
45
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.
CONDITIONS
Official Title
Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed persistent or locoregionally recurrent head and neck squamous cell carcinoma of oral cavity, pharynx, larynx, unknown primary head and neck
- Disease must be resectable as determined by the surgeon and team
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- At least 18 years of age
- Adequate hematologic, renal, and hepatic function
- At least 2 weeks washout period from prior therapy
- Willingness and ability to provide informed consent
- Negative pregnancy test for females of reproductive potential
- Prior cancer therapies allowed if patient has recurred
- Disease measurable by CT or MRI per RECIST 1.1 criteria
- Prior definitive and palliative chemotherapy allowed
- Prior radiation therapy allowed
- Tumor tissue, urine, and blood samples must be provided for biomarker analyses as scheduled
- White blood cell count 2000/uL or higher (within 14 days of randomization)
- Neutrophils 1500/uL or higher (within 14 days of randomization)
- Platelets 100,000/uL or higher (within 14 days of randomization)
- Hemoglobin greater than 9.0 g/dL (within 14 days of randomization)
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance 40 mL/min or higher (within 14 days of randomization)
- AST and ALT less than or equal to 3 times institutional upper limit of normal
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal (except for Gilbert Syndrome patients with bilirubin less than 3.0 mg/dL)
- Women of childbearing potential must use effective contraception during and for four months after treatment
- Women of childbearing potential must have a negative pregnancy test
- Men sexually active with women of childbearing potential must use contraception during and for four months after treatment
You will not qualify if you...
- Need for immunosuppressive therapy within 14 days of randomization
- Salivary gland carcinomas, lip carcinoma, or adenocarcinoma of the skin
- Prior use of immune checkpoint blockade agents
- Positive test or history of HIV, hepatitis B or C infection
- Unresectable disease as determined by the surgeon and team
- History of grade 3 toxicity with prior immunotherapy
- Presence of distant metastases
- Active autoimmune disease
- Breastfeeding women
- Additional malignancy within the past 3 years except certain skin and cervical cancers
- Palliative radiotherapy less than 14 days before first study drug dose
- History of hypersensitivity to any trial medications
- Serious medical or psychiatric illness interfering with study participation
- Prisoners or involuntarily incarcerated individuals
- Patients unavailable for follow-up or future contact
- Concurrent participation in other clinical trials is allowed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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