95 16.1 Appendix A Performance Status Criteria ................................................................... 95 7 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 STATEMENT OF COMPLIANCE The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the following: • United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) National Institutes of Health (NIH) -funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH- funded clinical trials have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval.