A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (mRNA-4157-P201)
This is an open-label, randomized, Phase 2 study. Approximately 150 eligible patients will be randomly assigned in a 2:1 ratio to the combination arm (approximately 100 patients who receive mRNA-4157 and pembrolizumab) and the control arm (approximately 50 patients who receive pembrolizumab alone). Patients with completely resected cutaneous melanoma at one of the following stages: ? Stage IIIB, only if relapsed within 3 months of initial surgery of curative intent. That is, the patient must have relapsed within 3 months of their first surgery of curative intent and subsequently had a second surgery of curative intent before entering this study (as such, newly diagnosed Stage IIIB patients are not eligible).? Stage IIIC.? Stage IIID.? Stage IV.Patients must have had complete resection (surgery of curative intent) within 13 weeks before study enrollment, and must be disease free at study entry (screening). Once a patient is enrolled, they will be randomized and should commence pembrolizumab treatment as soon as possible (ideally within 13 weeks of their surgery of curative intent). For patients randomly assigned to the mRNA-4157 plus pembrolizumab combination arm:? A pembrolizumab run-in period, typically 2 pembrolizumab cycles, will occur while mRNA-4157 is being manufactured.? Once a patient’s mRNA-4157 is available, the combination treatment period will commence. The first dose of mRNA-4157 will be administered with the next dose of pembrolizumab in order to achieve synchronous combination dosing in 21-day cycles.All patients on both arms of the study may continue on pembrolizumab until disease recurrence, unacceptable toxicity, or they undergo 18 total cycles (approximately 1 year of treatment), whichever is sooner. Crossover to the mRNA-4157 and pembrolizumab combination arm is not permitted for patients who relapse following pembrolizumab monotherapy. Recurrence-free survival (RFS) is the primary endpoint of the trial and is defined as the time between the first dose of pembrolizumab and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma or death (from any cause), whichever occurs first. Patients will be assessed for recurrence by radiological imaging.
A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients with Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib
This study is about testing two different treatments for a type of lung cancer called EGFR-mutant lung cancer. The first treatment is a medicine called osimertinib, which patients will take by mouth every day. They'll take it for three rounds, and then the doctors will check their blood to see if themedicine is working. If the medicine is not working, some patients will getanother treatment called chemotherapy along with osimertinib, while otherswill keep taking osimertinib alone. The doctors will monitor how well thetreatments are working by taking pictures of the inside of the body andchecking the blood again if the cancer starts to grow again.
A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Na ve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer
A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naïve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer
A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer
This study aims to see how well a new drug, EIK1001, works when given with pembrolizumab and certain chemotherapies in patients with Stage 4 lung cancer who haven't had other treatments. Patients will getEIK1001 through an IV once a week, and pembrolizumab every three weeks for up to 35 cycles. There are two groups: one will get EIK1001 with pemetrexed and carboplatin, and the other with paclitaxel and carboplatin. At first, a small number of patients will get a low dose of EIK1001 to check for serious side effects. If it’s safe, more patients will get a higher dose. The main goal is to see if the treatment has few side effects. The study will also look at how well the treatment works against the cancer, how long patients live without the cancer getting worse, and other important health markers. Patients will have regular scans to check their cancer and will be watched closely for side effects. The treatment will continue until the cancer worsens, side effects are too severe, or other reasons the study teams decides is good enough for patient withdrawal. After treatment ends, patients will be followed for at least 90 days to monitor their health.
A Phase 2/3 Adaptive Double-blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Adult and Pediatric subjects With APOL1-mediated Proteinuric Kidney Disease
This is an adaptive Phase 2/3 study of VX-147 in subjects Adult and Pediatric with APOL1-mediated proteinuric kidney disease that is designed to select a dose of VX-147 and establish the efficacy and safety of the selected dose
A Phase 2/3 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Epilepsy
The main purpose of this study is to understand whether BHV-7000 can help reduce the number of seizures in subjects with difficult to control or refractory focal epilepsy when compared to placebo (“dummy pill” or “inactive drug”). BHV-7000 was designed to open potassium channels called Kv7 on the surface of brain cells. Kv7 channels regulate brain activity or “neuroexcitability.” BHV-7000 makes Kv7 channels open more often and slows their deactivation. There are existing treatments for seizures called ASMs. However, many patients with focal epilepsy still have seizures while on ASMs. This is called focal refractory epilepsy. When seizures are not controlled by medications, they can cause injury, difficulty in school or work, and loss of freedom. Even when seizures are under control, ASMs often have side effects that impact quality of life. There is an unmet need for safe and effective treatments in refractory focal epilepsy.
A Phase 2/3 randomized double-blind placebo controlled parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD)
The purpose of this research study is to test if belimumab is well-tolerated, works well and helps treat interstitial lung disease and other aspects of disease associated with systemic sclerosis such as skin thickening.
A Phase 2a Multicenter Randomized Double-Blind Placebo- Controlled Study of the Safety and Efficacy of TB006 in Participants with Parkinson s Disease
The purpose of this study is to see if the study drug improves motor function in Parkinson's disease (PD) patients.
A Phase 2a Multicenter Randomized Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate the safety and efficacy of using multiple investigational medicines compared to a single medicine in subjects with moderate to severe Crohn’s Disease. The medicines being used in this study are Risankizumab, ABBV-382, and Lutikizumab.
A Phase 2b / 3 Multicenter Randomized Double-blind Placebo-controlled Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis
The purpose of this research study is to see if CSL300 (Clazakizumab) is effective and safe in patients on maintenance dialysis at reducing the risk of dying from heart-related events or having a heart attack.