Actively Recruiting
HNSALV Trial Combining Immunotherapy With Salvage Surgery and Intraoperative Radiation Therapy for Treatment of Persistent or Recurrent Head and Neck Cancers
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-02
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of pembrolizumab, a type of immunotherapy, with radiation therapy and surgery for patients with head and neck squamous cell cancer that has persisted or returned after previous treatment. This phase I trial aims to understand the possible side effects and how well this combined approach works in controlling the cancer locally and improving survival. The study also investigates how different radiation doses affect the immune response and certain biomarkers, as well as assessing quality of life during treatment. Participants are randomly assigned to one of three groups. All receive pembrolizumab intravenously starting in the first week, followed by surgery around week 4 or 8 depending on the group. Some groups also receive external beam radiation therapy (either low or high dose) before surgery. Intraoperative radiation therapy (IORT) is delivered during or shortly after surgery. After surgery, pembrolizumab is given every three weeks for up to 18 doses, with treatment continuing if the patient is tolerating it and benefiting clinically. During the study, patients undergo regular follow-ups to monitor side effects, cancer control, survival, and quality of life for up to five years. Researchers collect tumor tissue, blood, and urine samples for biomarker analysis. Assessments include imaging scans to measure disease status and quality of life questionnaires. The study tracks adverse events and evaluates how well patients respond to the treatment combination over time, with ongoing safety and efficacy monitoring.
CONDITIONS
Brief 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 (HNSCC) of oral cavity, pharynx, larynx, or unknown primary
- Resectable disease determined by surgeon and team
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- At least 18 years of age
- Adequate blood, kidney, and liver function
- At least 2 weeks since prior cancer therapy
- Willing and able to provide informed consent
- Negative pregnancy test for females of childbearing potential
- Prior therapy such as surgery, chemotherapy, or radiotherapy with recurrent disease
- Disease measurable by CT or MRI per RECIST 1.1 criteria
- Prior definitive and palliative chemotherapy allowed
- Prior radiation therapy allowed
- Must provide tumor tissue, urine, and blood samples as scheduled
- White blood cell count at least 2000/uL within 14 days before randomization
- Neutrophils at least 1500/uL within 14 days before randomization
- Platelets at least 100,000/uL within 14 days before randomization
- Hemoglobin greater than 9.0 g/dL within 14 days before randomization
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 40 mL/min
- 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 Gilbert Syndrome patients)
- Women of childbearing potential must use contraception during and for four months after treatment
- Men sexually active with women of childbearing potential must use effective contraception for four months after treatment
You will not qualify if you...
- Need for immunosuppressive therapy within 14 days before randomization
- Salivary gland carcinomas, lip carcinoma, or skin adenocarcinoma
- Prior use of immune checkpoint blockade agents
- Positive for HIV, hepatitis B or C infection
- Unresectable disease
- History of severe toxicity from prior immunotherapy
- Presence of distant metastases
- Active autoimmune disease
- Breastfeeding women
- Other cancers within the past 3 years (except certain skin and cervical cancers)
- Palliative radiotherapy less than 14 days before first dose of study drug
- Known allergy to trial medications
- Serious medical or psychiatric conditions interfering with participation
- Prisoners or involuntarily incarcerated individuals
- Not available for follow-up or future contact
- Participation in other clinical trials is allowed under this protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 12 weeks depending on treatment arm
Participants receive pembrolizumab, undergo salvage surgery, external beam radiation therapy (EBRT) if assigned, and intraoperative radiation therapy (IORT) according to their randomized treatment arm.
Multiple visits including initial pembrolizumab infusion, surgery, 2 EBRT fractions (if applicable), IORT, and pembrolizumab infusions every 3 weeks for up to 18 doses
Duration - Up to 5 years
Participants are followed for safety, efficacy, and quality of life assessments after treatment completion, including monitoring for adverse events, tumor response, and survival.
Visits at 90 and 180 days post-treatment, then every 90 days for 24 months, then every 6 months up to year 5
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here