Clinical Trials | A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC)

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have been diagnosed with recurrent or metastatic Head and Neck Cancer (HNC) and high-risk Human Papillomavirus-16 (HPV16) infection. The purpose of this study is to test the effectiveness and safety of the combination of an investigational vaccine, PDS0101, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA®), given intravenously (“IV;” into the vein) compared to pembrolizumab (KEYTRUDA®) alone. This is a randomized study. Randomized means you will be selected by chance (e.g. like a flip of the coin) to receive one of two treatments as follows: Investigational Arm: Pembrolizumab (KEYTRUDA ®) and PDS0101 OR Control Arm: Pembrolizumab (KEYTRUDA ®) alone You have a 2 out of 3 chance to receive the Investigational Arm and a 1 out of 3 chance to receive the Control Arm [referred to as a 2:1 randomization]. You are expected to be in this research study for up to 2 years. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT06790966 [email protected]