HNSALV Trial: Combining Immunotherapy With Salvage Surgery and IORT for Treatment of Persistent/Recurrent Head and Neck Cancers
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.
• 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