A Phase 2 randomized open-label active-controlled study of JNJ-90301900 in combination with chemoradiation followed by durvalumab in locally advanced and unresectable Stage III non-small cell lung cancer
This is a Phase 2 study testing whether adding a new medicine, JNJ-90301900 (radioenhancer) to the standard treatment of chemotherapy and radiation, followed by a medication called durvalumab (a type of immunotherapy) can be a better treatment option for patients with a type of lung cancer called non-small cell lung cancer (NSCLC). This study will be done in two parts. In Part 1, patients will be enrolled sequentially into two groups to receive a JNJ-90301900 injection at two different dose levels along with standard treatment of chemotherapy and radiation, followed by a medication called durvalumab. In part 2, the patients will be randomly divided into three groups. Patients in Groups A and B will receive the study medicine at two different dose levels along with standard treatment of chemotherapy and radiation, followed by a medication called durvalumab. Patients in Group C will receive the standard chemotherapy and radiation treatment, followed by a medication called durvalumab. The study will compare the effects of this new combination treatment with those of the standard treatment alone. All patients will have blood samples taken to see how their bodies handle the study medicines and how well the cancer responds to this treatment over time. Patients will have special scans taken to monitor how the cancer is changing in response to the study medication. The study team will monitor all patients for side effects and safety concerns throughout the study. All patients will be followed up after their last study dose for up to 24 months.
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 2/3 RANDOMIZED OPEN-LABEL MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FPI-2265 (225AC-PSMA-I&T) IN PATIENTS WITH PSMA-POSITIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) PREVIOUSLY TREATED WITH 177LUPSMA RADIOLIGAND THERAPY (RLT)
This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The doseoptimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of noveldosing regimens of FPI-2265 with a subsequent Phase 3 efficacy evaluation of FPI-2265 vs SOC inextending rPFS, measured by the PCWG3 criteria, in participants with PSMA-positive mCRPC whohave been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy(RLT).SOC will be determined by the treating physician/Investigator prior to randomization. FDA-approvednovel androgen receptor pathway inhibitors for mCRPC (such as abiraterone or enzalutamide) areallowed. Investigational agents, cytotoxic chemotherapy, immunotherapy, other systemicradioisotopes, and hemi-body radiotherapy are excluded.The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265dose and regimen for the subsequent efficacy evaluation segment (Phase 3). Conclusions from Phase2 will be based on safety, tolerability, and anti-tumor activity. The primary objective of Phase 3 is toevaluate the anti-tumor activity, measured by rPFS, in participants with progressive PSMA-positivemCRPC who receive FPI-2265 vs participants treated with SOC.
A Phase 2a Study with Safety Run-in to Evaluate the Safety Tolerability and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors
This is a medical study testing a drug called FF-10832 alone and with another medicine called pembrolizumab for patients with advanced solid tumors. First, patients will try both drugs together to make sure there minimum side effects. The study team will use FF-10832 at a certain dose with a fixed amount of pembrolizumab. If there are minimum to no side effects, the study team might try a lower dose for more patients. They'll keep checking and might use even smaller doses if needed and approved. Then, the study team will bring in more patients with two types of cancer: one in the bladder (urothelial cancer) and another in the lungs (non-small cell lung cancer). Each group of patients will be split into four smaller groups. These patients' cancers got worse after PD-1/PD-L1 therapy. Some patients will get just one drug, while others will get both, to see how safe and helpful FF-10832 is alone or with pembrolizumab. The study team might also include more types of cancer based on the first safety check.