Patient-derived organoid model and circulating tumor cells for treatment response of lung cancer Patient-derived organoid model and circulating tumor cells for treatment response of lung cancer Create a living biobank of PDOs from Stage I-III lung cancer patients.NCT03655015Josephine Taverna, MD

MONITOR-Breast: Monitoring cell-free tumor DNA as a marker of recurrence in Breast Cancer MONITOR-Breast: Monitoring cell-free tumor DNA as a marker of recurrence in Breast Cancer This is a prospective, observational study designed to evaluate the clinical validity of Myriad Genetics’ MRD test in patients diagnosed with breast cancer. It is expected that enrollment will be split between the different breast cancer subtypes defined by immunohistochemistry (HR+/HER2-, HER2+ (HR+ and HR-), TNBC) and according to BINV-A of National Comprehensive Cancer Network guidelines with ER+ status used here as >10% of nuclei staining.ClinicalTrials.gov registration not requiredMarcela Mazo Canola MD

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