Medicines that are not part of the study treatment will not be provided or paid for by the NIH Clinical Center. 3.5.2 Compensation There will be no compensation provided in this study. 3.5.3 Reimbursement On this study, the NCI will cover the cost for some of the expenses. Some of the costs may be paid directly by the NIH and some may be reimbursed to the subject. Someone will work with subjects to provide more information. 3.6 CRITERIA FOR REMOVAL FROM PROTOCOL THERAPY AND OFF STUDY C RITERIA After completing the study treatment, effort must be made to have all subjects complete the scheduled follow up on day 49. 3.6.1 Criteria for removal from protocol therapy Completion of protocol therapy Participant requests to be withdrawn from active therapy Unacceptable toxicity (see section 3.1.2) Positive pregnancy test or intent to become pregnant Investigator discretion Initiation of alternative anticancer therapy including another investigational agent. Intercurrent illness that prevents further administration of treatment, in the judgement of the investigator 3.6.2 Off-Study Criteria Death Completion of 2-year study follow up period Subject is lost to follow up* Subject requests to be removed from the study Investigator discretion PI decision to close the study 3.6.3 Lost to Follow-up* A participant will be considered lost to follow-up if he or she is unable to be reached after reasonable effort is made by the study site staff (for example, 3 telephone calls and, if necessary, an IRB approved certified letter to the participant’s last known mailing address or local 39 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022 equivalent methods). These contact attempts should be documented in the participant’s medical record or study file.