A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder CancerA Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder CancerThis is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.ClinicalTrials.gov registration not requiredAhmed Mansour Elkenany MD

Genetics & Biology of Liver Tumorigenesis in ChildrenGenetics & Biology of Liver Tumorigenesis in ChildrenThe overall goals of this Multi-Investigator Research Proposal is to further the understanding of the development and identify prognostic characteristics of liver tumors in children, particularly hepatoblastoma and its variants through a combined genomic and molecular pathology approach.ClinicalTrials.gov registration not requiredGail Tomlinson MD, PhD

Genetic Epidemiology of Breast and Ovarian CancersGenetic Epidemiology of Breast and Ovarian CancersA research study about factors that might increase the chance of getting breast and ovarian cancers. Eligible: female 18-80 yr old; diagnosed with breast cancer under age 50; diagnosed with ovarian cancer at any age; strong family history of breast and/or ovarian cancer.ClinicalTrials.gov registration not requiredGail Tomlinson MD, PhD

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 Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoA 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 Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-PoThis is a Phase 3 open-label, active-control, 2:1 randomized study with parallel assignment of PDS0101 plus pembrolizumab (referred to as ‘the investigational arm’) vs pembrolizumab alone (referred to as ‘the control arm’) in immune checkpoint inhibitor (ICI) naïve subjects with first line unresectable recurrent and/or metastatic (R/M) HPV16-positive HNSCC with a CPS ≥ 1.NCT06790966Devi Meyyappan MD