1 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Abbreviated Title: Combo Immunotx in HPV Cancers NIH Protocol #: 20C0045 Version Date: May 12, 2023 NCT Number: NCT04287868 RSC Number: 2744 Title: Phase I/II Trial of Combination Immunotherapy in Subjects with Advanced HPV Associated Malignancies NCI Principal Investigator : Charalampos Floudas, MD, DMSc, MS Center for Immuno-Oncology (CIO) Center for Cancer Research (CCR) National Cancer Institute (NCI) 10 Center Drive Building 10, Room 7N240A Bethesda, MD 20892 Phone: 240-858-3032 Email: charalampos.floudas@nih.gov Drug Name: PDS0101 MSB0011359C (M7824) NHS -IL12 (M9241) IND Number: 019267 019267 019267 Sponsor: Center for Cancer Research, NCI Center for Cancer Research, NCI Center for Cancer Research, NCI Manufacturer: PDS Biotechnology EMD Serono, Inc. EMD Serono, Inc.