Primary and final analyzed data will have identifiers so that research data can be attributed to an individual human subject participant. All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. Document AEs from the first study intervention, study day 1, through 30 days after the subject received the last product administration. After 90 days, only adverse events which are grade 3 or higher and possibly related to the study investigational agent need to be recorded. An abnormal laboratory value will be recorded in the database as an AE only if the laboratory abnormality is characterized by any of the following: Results in discontinuation from the study Is associated with clinical signs or symptoms Requires treatment or any other therapeutic intervention Is associated with death or another serious adverse event, including hospitalization. Is judged by the Investigator to be of significant clinical impact If any abnormal laboratory result is considered clinically significant, the investigator will provide details about the action taken with respect to the test drug and about the patient’s outcome. End of study procedures: Data will be stored according to HHS, FDA regulations, and NIH Intramural Records Retention Schedule as applicable. Loss or destruction of data: Should we become aware that a major breach in our plan to protect subject confidentiality and trial data has occurred, this will be reported expeditiously per requirements in section 7.2.1. 6.2 DATA SHARING PLANS 6.2.1 Human Data Sharing Plan What data will be shared? I will share human data generated in this research for future research as follows Coded, linked data in an NIH-funded or approved public repository. Coded, linked data in BTRIS (automatic for activities in the Clinical Center) Identified or coded, linked data with approved outside collaborators under appropriate agreements. How and where will the data be shared? An NIH-funded or approved public repository: clinicaltrials.gov, dbGaP BTRIS (automatic for activities in the Clinical Center) Approved outside collaborators under appropriate individual agreements. Publication and/or public presentations. 51 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022 When will the data be shared? Before publication.