Ohio State University Comprehensive Cancer Center
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.
PRIMARY OBJECTIVE: I. To evaluate the potential toxicity of immunotherapy and preoperative radiation combined with intra-operative radiation in patients with recurrent or persistent head and neck squamous cell carcinoma (HNSCC). SECONDARY OBJECTIVES: I. To evaluate the clinical efficacy, measured as a locoregional control rate (LCR) and progression-free survival (PFS), of immunotherapy and preoperative radiation combined with intra-operative radiation in patients with recurrent or persistent HNSCC. II. To evaluate the pre-operative radiation dose effect (0 Gy, 2 Gy X 2, 8 Gy X 2) on anti-t…
Inclusion Criteria: * 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…
Undergo EBRT
Undergo IORT
Given IV
Ancillary studies
Undergo salvage surgery
Arctuva estimate
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