Hasselt

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating the safety and effectiveness of pulsed field ablation (PFA) therapy for treating persistent atrial fibrillation (PersAF) that does not respond to medication. The study compares PFA targeting pulmonary veins plus extra-PV sources identified by electrographic flow (EGF) mapping against PFA targeting pulmonary veins plus the left atrial posterior wall (PVI + PWA). The goal is to establish safety and to show that the new method is not less effective than the current approach in patients with symptomatic, drug-refractory PersAF. Participants will receive treatment using several devices, including the FARAPOINT Pulsed Field Ablation System, the OptiMap System for electrogram analysis, and the FARAWAVE NAV Catheter combined with the Opal HDx Mapping System for detailed heart mapping. All subjects will undergo electroanatomical mapping of the entire left atrium, followed by pulsed field ablation of the pulmonary veins, with additional ablation of either EGF-identified sources or the posterior wall, depending on the assigned treatment group. During the study, participants will be monitored for safety outcomes at 60 days and effectiveness outcomes at 365 days. They will receive a LUX-Dx insertable cardiac monitor to track heart rhythm continuously. Researchers will collect clinical data, imaging, and follow-up assessments to evaluate treatment impact and safety. The study includes ongoing follow-up visits to ensure thorough monitoring of heart function and study outcomes over one year.

Researchers are evaluating the safety and effects of fosmanogepix, a study medicine, for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida species. This Phase 3 clinical trial compares fosmanogepix to the standard treatment of caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard therapy by a margin of 15%. The study includes adult patients diagnosed with these infections. Participants will receive either fosmanogepix or caspofungin as an intravenous infusion daily at the study clinic. After the initial infusion phase, patients may switch to oral tablets of fosmanogepix or fluconazole capsules, which can be taken at the clinic or at home if discharged. Treatment duration varies by individual, lasting up to six weeks depending on infection clearance and symptom improvement. A follow-up visit will take place six weeks after stopping treatment. During the study, patients will undergo multiple visits to monitor their health and treatment response. Researchers will assess outcomes such as the proportion of patients alive at 30 days and the overall treatment success at the end of study treatment, up to day 42. Safety will be closely monitored throughout the study and during follow-up, ensuring comprehensive evaluation of the treatments over the entire participation period.

Researchers are evaluating the recurrence-free survival of women with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary after complete tumor removal. This phase II, randomized, open-label study compares two treatment strategies involving chemotherapy and maintenance therapy with niraparib. The study focuses on patients with no residual tumor mass following primary tumor debulking and aims to determine if fewer cycles of chemotherapy followed by niraparib maintenance are as effective as the standard number of chemotherapy cycles plus niraparib. Participants are randomly assigned to one of two groups: one receiving 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance, and the other receiving 6 cycles of carboplatin plus paclitaxel followed by niraparib maintenance. Randomization is based on genetic analysis and disease stage. Tumor assessments using CT or MRI scans will be done at defined intervals after treatment starts and during maintenance. Blood markers and safety monitoring will be conducted regularly throughout the treatment period. During the study, patients will have clinical visits every 3 weeks during chemotherapy and monthly during the first 11 months of maintenance, then quarterly thereafter. Safety is monitored continuously through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in six European countries over 36 months. The primary outcome measured is recurrence-free survival over 8 years.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the safety and effectiveness of various new drug combinations, including novel agents combined with standard treatments, for people with advanced or metastatic non-small cell lung cancer (NSCLC). This open-label, multicenter trial focuses on sub-study 2, which examines rilvegostomig combined with standard platinum-based chemotherapy, with or without ramucirumab, in participants with advanced NSCLC. The study aims to identify optimal doses and expand cohorts to better understand treatment safety and tumor response. The trial involves two parts: Part A includes safety run-in groups to test different dose levels of rilvegostomig and establish the recommended Phase 2 dose if not already known. Part B expands to larger groups to assess treatment effects. Rilvegostomig and other study drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, and ramucirumab are given by intravenous infusion according to the study protocol. Sub-study 1 was canceled and will not take place. Participants will undergo assessments including tumor tissue sampling, disease measurement scans, and laboratory tests to monitor organ function and treatment effects. Researchers will track adverse events, serious adverse events, dose-limiting toxicities, and tumor responses over approximately 46 months. Safety, tolerability, and anti-tumor activity are key outcomes, with follow-up to ensure participant well-being and gather comprehensive data on these novel treatment combinations.

Researchers are evaluating the safety and feasibility of a new paddle-shaped, high-density, multi-electrode mapping catheter designed to map the atrial and ventricular regions of the heart. This study focuses on patients with various arrhythmias, including scar-related atrial tachycardia, persistent and paroxysmal atrial fibrillation, ventricular tachycardia, ischemic and non-ischemic ventricular tachycardia, cardiomyopathy, idiopathic ventricular tachycardia, and premature ventricular contraction. The goal is to assess how well the investigational catheter performs during endocardial mapping procedures. Participants will undergo mapping procedures using the investigational high-density multi-electrode catheter. The catheter will be used during clinically indicated catheter mapping and ablation procedures targeting ventricular tachycardia, premature ventricular complex, atrial tachycardia, or atrial fibrillation. The study includes monitoring for completion of all pre-ablation mapping requirements and any additional clinically needed mapping. This device-based intervention is evaluated up to 7 days after the index procedure. During the study, participants will be closely monitored for any serious adverse events related to the investigational catheter within 7 days after the procedure. Researchers will assess the success of mapping procedures and collect safety data. Participants must be willing and able to comply with all testing and follow-up requirements. The study includes safety monitoring and evaluation of the catheter's ability to complete mapping tasks essential for treatment planning.

Researchers are evaluating treatments for people with extensive stage small-cell lung cancer (ES-SCLC). This phase 3 study compares the effectiveness of adding tarlatamab to a combination of durvalumab, carboplatin, and etoposide against the combination without tarlatamab. The main goal is to see which treatment better prolongs overall survival and progression-free survival over about 3.5 years. Participants receive intravenous infusions of the study drugs. One group gets tarlatamab combined with durvalumab, carboplatin, and etoposide, while the other group receives durvalumab, carboplatin, and etoposide alone. All treatments are given as first-line therapy for their lung cancer. During the study, participants will be monitored regularly to assess their response to treatment and overall health. Researchers will measure overall survival and progression-free survival to evaluate treatment benefit. The study also involves ongoing safety monitoring, and participants will be followed for up to approximately 3.5 years to collect these outcomes.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

Researchers are evaluating the safety, how the body processes the drug (pharmacokinetics), and the activity of divarasib alone or combined with other anti-cancer treatments in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not received previous treatment. This study focuses on patients with a specific KRAS G12C mutation and includes both Phase Ib and II stages to understand the drug effects better. Participants will receive divarasib orally once daily on days 1 to 21 during each 21-day treatment cycle. Depending on the treatment group, participants may also receive pembrolizumab, an intravenous infusion given every three weeks, and chemotherapy drugs such as carboplatin or cisplatin administered intravenously every three weeks for four cycles. Pemetrexed, another chemotherapy drug, may be given intravenously every three weeks as well. These treatments are designed to be studied either alone or in combination. Throughout the study, participants will be monitored for any adverse events from the start of treatment until 60 days after the last dose or until they begin another anti-cancer therapy, up to about five years. Researchers will conduct evaluations including tumor measurements, safety assessments, and pharmacokinetic sampling. The study requires participants to have measurable disease and good performance status. Close monitoring will ensure participant safety and collect data to understand the drug’s activity and side effects over time.