Human Papillomavirus clinical trials at UCLA

An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.

Every year, thousands of Americans die from cancers related to human papillomavirus (HPV). The vast majority of those deaths could be prevented with a safe and effective vaccine, yet many parents choose not have their children vaccinated when it is recommended at age 11 or 12. In this study, we will examine in a randomized trial whether earlier initiation of the vaccine at age 9-10 years will result in less parental refusal and higher rates of full vaccination at younger ages, before early sexual activity begins.