A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
This will be a long-term multi-center study to comprehensively study patients with primary liver cancer (PLC).ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor IndicationsA Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor IndicationsClinicalTrials.gov registration not required

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480), Bortezomib, and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMMA Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480), Bortezomib, and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMMTo compare the progression-free survival (PFS) of mezigdomide (CC-92480, also known as BMS-986348), bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)NCT05519085Matthew Butler, 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

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk A Study of imlunestrant vs physician’s choice endocrine therapy as adjuvant treatment after 2 to 5 years of standard adjuvant endocrine therapy for patients with ER+, HER2- early breast cancer with an increased risk of recurrenceClinicalTrials.gov registration not requiredVirginia Kaklamani, MD, DSc

S2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreS2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreThis clinical trial aims to validate the results observed in I-SPY2 and will test if adding durvalumab to neoadjuvant chemotherapy can increase pCR rates, shift residual cancer burden to lower values and improve invasive breast cancer free survival in early-stage HRpositive MP2 cancers.ClinicalTrials.gov registration not requiredKate Lathrop M.D.

A First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell MalignanciesA First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell MalignanciesM22-716 is a Phase 1, FIH, open-label, dose escalation, dose expansion, biomarker/pharmacodynamic (PD) study of ABBV-319 in participants with relapsed or refractory (R/R) B-cell malignancies.NCT05512390Daruka Mahadevan, MD, PhD

S2302, PRAGMATICA – LUNG - A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small S2302, PRAGMATICA – LUNG - A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.ClinicalTrials.gov registration not requiredSherri Cervantez, 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

A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid TumorsA Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid TumorsTo evaluate the safety, tolerability, MTD and the RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available.ClinicalTrials.gov registration not requiredDaruka Mahadevan, MD, PhD