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

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.NCT06479135Zohra Nooruddin MD

Clinical Trial

A Phase II multicenter, open-label, single-arm dose escalation study of Asciminib monotherapy in 2nd and 1st Line Chronic Phase – Chronic Myelogenous Leukemia (ASC2ESCALATE) (CTMS# 23-0101)

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning, or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.