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Immunotherapy and Radiation for Recurrent Head and Neck Cancer

This study is for people with head and neck squamous cell cancer that has not gone away after treatment (persistent) or has returned (recurrent). It's looking at the safety and effectiveness of combining the immunotherapy drug pembrolizumab with radiation therapy, given before and during surgery. Pembrolizumab works by helping your immune system fight cancer. Radiation therapy uses high-energy rays to kill cancer cells. Researchers want to see if this combination can kill more cancer cells and improve quality of life. You may be able to join if you are at least 18 years old, your cancer can be removed by surgery, and you meet other health requirements. The study will also look at how long people live without their cancer growing and how long they live overall.

Study design
This interventional study plans to enroll 45 participants. It is not specified if it is a randomized or single-arm study, or its phase.
What's involved
You would undergo salvage surgery, external beam radiation therapy (EBRT), and intraoperative radiation therapy (IORT). You would also receive pembrolizumab intravenously and complete quality-of-life assessments. Adverse events will be measured for up to 100 days after your last dose of pembrolizumab.
Compensation
Not stated in the trial record.
Follow-up
Your health-related quality of life will be measured for up to 5 years after the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04754321

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Ohio State University Comprehensive Cancer Center
~45 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:External Beam Radiation TherapyIntraoperative Radiation TherapyPembrolizumabQuality-of-Life AssessmentSalvage Surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 100 days after last dose of study drug
+1 more outcome measured

Conditions

Head and Neck Carcinoma of Unknown Primary
Locally Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Pharyngeal Squamous Cell Carcinoma
Resectable Head and Neck Squamous Cell Carcinoma

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Head and Neck Carcinoma of Unknown PrimaryHead and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Dukagjin M Blakaj, MD, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H\&N) squamous cell carcinoma
Resectable disease as determined by the surgeon and team
Eastern Cooperative Oncology Group (ECOG) performance status (PS) \< 2
At least 18 years of age
Adequate hematologic, renal, and hepatic function
Must have at least 2 week washout period from prior therapy
Willingness and ability to provide informed consent
Negative pregnancy test for females of reproductive potential
Patients who have undergone therapy for their cancer, such as surgery and/or chemotherapy and/or radiotherapy and recurred
Disease measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
Prior definitive and palliative chemotherapy will be allowed
Prior radiation therapy will be allowed
Tumor tissue from resected site of disease must be provided for biomarker analyses, in addition to urine and blood sample as scheduled per protocol
White blood cell (WBC) \>= 2000/uL (obtained within 14 days of randomization)
Neutrophils \>= 1500/uL (obtained within 14 days of randomization)
Platelets \>= 100 x10\^3/uL (obtained within 14 days of randomization)
Hemoglobin \> 9.0 g/dL (obtained within 14 days of randomization)
Serum creatinine =\< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) \>= 40 mL/min (Cockcroft and Gault or Wright formula may be used according to local practice) (obtained within 14 days of randomization)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN
Total Bilirubin =\< 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for four months after the last dose of pembrolizumab.
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\])
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of four months after the last dose of investigational product

Exclusion

Requirement of immunosuppressive therapy within 14 days of randomization
Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin
Prior use of immune checkpoint blockade agent
History of human immunodeficiency virus (HIV), hepatitis B, C: Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection, those who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)
Unresectable disease, as determined by the surgeon and team
Subjects with history of grade 3 toxicity with prior immunotherapy
Patients with distant metastases
Subjects with active autoimmune disease
Breastfeeding women
Additional prior malignancy within the previous 3 years (treated or untreated, except for skin carcinomas treated with excision alone and carcinoma in situ of the cervix)
Palliative radiotherapy less than 14 days prior to first dose of study drug
Any history of hypersensitivity to any of the trial medications
Poorly controlled or serious medical or psychiatric illness likely to interfere with participation and/or compliance in this clinical trial
Prisoners or subjects who are involuntarily incarcerated
Patients not available for follow-up/future contact as defined in the ICF
Note: Patients on this protocol are not excluded from participation in other clinical trials

What this trial measures

  • Incidence of adverse eventsUp to 100 days after last dose of study drug

    Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Summarized by treatment group. All on-study adverse events (AEs), treatment-related AEs, serious (S)AEs, and treatment-related SAEs will be tabulated using worst grade per NCI CTCAE version 4.0 criteria by system organ class and preferred term. On-study lab parameters including hematology, chemistry, liver function, and renal function will also be summarized using worst grade NCI CTCAE v 4.0 criteria. Toxicity will be measured as the rate of grade 3 and 4 adverse events and will be calculated through using the exact binomial distribution method with a 2- sided 95% confidence interval.

  • Health related quality of lifeUp to 5 years

    Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Analysis will be performed in all randomized participants who have an assessment at baseline and at least one follow-up assessment using linear mixed model for repeated measures to model the changes overtime for each arm.