Study design
immune-sensitive, tumor, intercurrent illness
ADVERSE EVENTS, DISEASE PROGRESSION, TUMOR
This is a single-arm, nonrandomized study to evaluate the feasibility, efficacy and tolerability of the combination of QS RT and pembrolizumab immunotherapy for patients with A/R/M HNSCC. Fifteen eligible patients will be enrolled and treated with standard of care pembrolizumab at a dose of 200 mg every 3 weeks until progression or treatment intolerance [Whenever tumor tissue is available, PD-L1 level will be tested using the Dako 22C3 assay [Patients will be removed from the treatment portion of the protocol if one of the following criteria applies: disease progression (not amenable to localized treatment), unacceptable adverse events, intercurrent illness that prevents further administration of treatment, patient decision to withdraw from the study or changes in patient condition rendering the patient ineligible for further treatment in the judgment of the treating oncologist. New patients will be enrolled to replace those who do not complete at least one QS treatment, those who do not undergo initial imaging response assessment and those who cannot provide scheduled correlative blood and saliva samples.Saliva and blood will be collected for correlative studies. A comprehensive translational analysis will interrogate the molecular and cellular immune response to ICI alone and in combination with RT in order to generate a proposed immune-sensitive profile and to describe the mechanisms of immune sensitization with hypofractionated RT in immune unresponsive patients.