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

APOBEC3 Expression in HPV-Related Malignancies as a Novel Biomarker of Response to Definitive ChemoradiationAPOBEC3 Expression in HPV-Related Malignancies as a Novel Biomarker of Response to Definitive ChemoradiationThis is a non-randomized biomarker study with the aim to evaluate the relationship between APOBEC3B (A3B) expression in primary head and neck cancers (HNC), anus, and cervix tumors and pathologic response to definitive chemoradiation therapy.ClinicalTrials.gov registration not requiredShraddha Dalwadi, MD, MBA

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger).ClinicalTrials.gov registration not requiredShraddha Dalwadi, MD, MBA

Shortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-Center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men with Node-Positive and High-Risk Node-Negative InvShortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-Center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men with Node-Positive and High-Risk Node-Negative InvTo learn about the effects of shorter RNI regimens in patients with breast cancer who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.NCT07076485Shraddha Dalwadi, MD, MBA

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous This is a Phase 2, randomized, active-controlled, parallel-group, multisite, open-label studyof belzutifan plus fulvestrant versus everolimus plus ETPC (fulvestrant or exemestane) inparticipants with ER+/HER2- unresectable, locally advanced, or mBC.ClinicalTrials.gov registration not requiredSaba Shaikh, MD

MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684 is being developed for treatment of solid tumors. This basket study of MK-5684 isdesigned to assess the safety, tolerability, and preliminary efficacy of MK-5684 in selectedadvanced solid tumor indications.ClinicalTrials.gov registration not requiredSaba Shaikh, MD

A Phase 2, Randomized, Multicenter, Open-Label Neoadjuvant Study Evaluating Zanidatamab in Combination with Chemotherapy in Participants with HER2-Positive Breast Cancer A Phase 2, Randomized, Multicenter, Open-Label Neoadjuvant Study Evaluating Zanidatamab in Combination with Chemotherapy in Participants with HER2-Positive Breast Cancer The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer.NCT07102381Saba Shaikh, MD