4 STATEMENT OF COMPLIANCE ................................................................................................ 7 1. INTRODUCTION .................................................................................................................. 7 1.1 Study Objectives .............................................................................................................. 7 1.2 Background and Rationale ............................................................................................... 8 2 ELIGIBILITY ASSESSMENT AND ENROLLMENT ....................................................... 30 2.1 Eligibility Criteria .......................................................................................................... 30 2.2 Screening Evaluation ...................................................................................................... 32 2.3 Participant Registration and Status Update Procedures ................................................. 34 2.4 Baseline Evaluation ........................................................................................................ 35 3 STUDY IMPLEMENTATION ............................................................................................ 35 3.1 Study Design .................................................................................................................. 35 3.2 Drug Administration ...................................................................................................... 39 3.3 Study Intervention Compliance ...................................................................................... 40 3.4 Dose Modifications ........................................................................................................ 40 3.5 Study Calendar ............................................................................................................... 51 3.6 Cost and Compensation .................................................................................................. 53 3.7 Criteria for Removal from Protocol Therapy and Off Study Criteria ............................ 53 4 CONCOMITANT MEDICATIONS/MEASURES .............................................................. 54 4.1 The Following Treatments Should Not Be Administered During the Trial ................... 54 5 CORRELATIVE STUDIES FOR RESEARCH/PHARMACOKINETIC STUDIES ......... 55 5.1 Biospecimen Collection ................................................................................................. 55 5.2 Samples for Genetic/Genomic Analysis ........................................................................ 57 5.3 Sample Storage, Tracking and Disposition .................................................................... 58 6 DATA COLLECTION AND EVALUATION ..................................................................... 60 6.1 Data Collection ............................................................................................................... 60 6.2 Data Sharing Plans ......................................................................................................... 61 6.3 Response Criteria ........................................................................................................... 61 6.4 Toxicity Criteria ............................................................................................................. 68 7 NIH REPORTING REQUIREMENTS / DATA AND SAFETY MONITORING PLAN .. 68 5 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 7.1 Definitions ...................................................................................................................... 68 7.2 OHSRP Office of Compliance and Training / IRB Reporting .......................................