Brasschaat

Researchers are studying an investigational drug called linvoseltamab in adults who have a moderate risk of developing multiple myeloma. This group includes patients with precancerous conditions known as High-Risk Monoclonal Gammopathy of Undetermined Significance HR-MGUS and Non-High-Risk Smoldering Multiple Myeloma NHR-SMM. The main goal is to understand how well linvoseltamab can eliminate abnormal plasma cells and laboratory signs associated with these conditions. Participants will receive linvoseltamab following a step-up dosing regimen to assess safety and tolerability before moving to one of four full dosing regimens. The study is divided into a safety run-in phase and an expansion phase where participants are assigned to different dose groups without randomization. Linvoseltamab is given according to the study protocol, with dosing schedules designed to monitor effects and side effects. During the study, participants will be closely monitored through regular safety observations over 35 days and longer-term assessments up to 5.5 years. Researchers will track adverse events, treatment responses including complete response rates, laboratory results, and the presence of antibodies against the drug. Blood levels of linvoseltamab are measured up to 9 months. This comprehensive monitoring will help understand the drugs impact and safety over time.

Researchers are evaluating the use of epigenome-guided treatment selection compared to the usual standard-of-care SOC treatment for adults with active Crohns Disease CD. This study aims to assess the effectiveness, safety, and cost-effectiveness of using an epigenetic biomarker assay and machine-learning software called EpiPredict to help choose between two biologic therapies, Vedolizumab VDZ and Ustekinumab UST, for treating active CD. The trial includes participants who have active disease and are either new to biologic therapy or have had limited prior biologic exposure. Participants will be randomly assigned to one of two groups one group will receive biologic treatment guided by the EpiPredict software based on epigenetic blood tests, which indicates the likelihood of response to VDZ or UST, while the other group will receive biologic therapy following usual SOC without epigenetic guidance. Both groups will receive their biologic therapy according to approved product labels, with dose adjustments allowed as needed by the treating doctor. Treatment and assessments will be carried out over 26 weeks, with different assessment schedules depending on the biologic received. After this treatment period, participants will have long-term follow-up every six months up to 24 months. During the study, participants will provide blood samples for epigenetic testing and undergo clinical and endoscopic evaluations to monitor their disease activity and response to treatment. Data will also be collected from routine medical records and online questionnaires during follow-up visits. The primary measurement is the comparison of clinical remission and endoscopic response rates at Week 26 between the two treatment selection methods. Researchers will also evaluate cost-effectiveness and explore how well the epigenetic assay predicts treatment success. Participants are required to comply with study procedures and provide informed consent to participate fully.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Colorectal cancer CRC is the third most common cancer worldwide. This study evaluates the safety and disease activity changes of telisotuzumab adizutecan combined with bevacizumab compared to the standard of care treatment of trifluridine and tipiracil LONSURF plus bevacizumab. It focuses on adults with refractory metastatic colorectal cancer whose tumors overexpress c-Met. The trial is a global Phase 3 study involving approximately 700 participants. Participants are randomly assigned to one of two groups. One group receives intravenous telisotuzumab adizutecan plus intravenous bevacizumab, while the other group receives the standard care which includes oral trifluridine and tipiracil combined with intravenous bevacizumab. Both treatments continue for about 36 months. The study compares these two regimens to assess their effects on disease progression and adverse events. During the trial, participants attend regular visits at approved hospitals or clinics. Researchers monitor treatment effects through medical exams, blood tests, and questionnaires to track side effects and changes in disease activity. The main outcomes assessed include objective response and overall survival over 15 to 36 months, with additional measures such as progression-free survival and quality of life evaluations. Safety and treatment impact are closely followed throughout the study period.

This research aims to evaluate the safety and effectiveness of Mirvetuximab Soravtansine in female participants aged 18 years and older who have platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high levels of folate receptor alpha FR. The study includes two groups a randomized Phase 2 group and a hepatic impairment group, with about 110 participants expected worldwide. The purpose is to better understand how this investigational antibody drug conjugate works by targeting cancer cells carrying FR to deliver a cell-killing drug. Participants in the randomized Phase 2 group receive Mirvetuximab Soravtansine intravenously on one of two schedules either a standard dose on day 1 every 21 days or a lower dose on days 1 and 15 every 28 days. The hepatic impairment group evaluates the starting dose for participants with moderately abnormal liver function, receiving different doses on day 1 of a 21-day cycle. Treatment and monitoring continue for up to about 24 months, including dose optimization and safety assessments. During the study, participants will visit the hospital or clinic regularly for medical exams, blood tests, and scans to track treatment effects and side effects. Researchers will measure responses including corneal adverse events, tumor response rates, drug concentrations in the body, and survival outcomes. Safety is closely monitored through assessments of vital signs, laboratory values, and physical exams. The total participation time is approximately 24 months, with ongoing evaluations to determine how well the treatment works and its safety profile.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

This research aims to evaluate the long-term safety of luspatercept in participants who have previously taken part in other luspatercept clinical trials for conditions such as Myelodysplastic Syndromes MDS, Beta-thalassemia, and Myeloproliferative Neoplasm-associated Myelofibrosis. It is a Phase 3b, open-label, single-arm rollover study designed to continue monitoring participants who tolerated previous luspatercept treatment and may benefit from ongoing therapy, as well as those in post-treatment follow-up phases. Participants transitioning from prior luspatercept studies will enter a Transition Phase defined by an enrollment visit. Those continuing treatment will receive luspatercept injections subcutaneously at the same dose and schedule as their parent trial, administered by study staff at clinical sites. The study includes a Treatment Phase for ongoing luspatercept administration and a Follow-up Phase comprising a 42-day safety follow-up after the last dose and a long-term post-treatment follow-up phase lasting at least 5 years to monitor overall survival and progression to malignancies. Throughout the study, participants will be regularly assessed for adverse events, progression to high-risk MDS or AML, and development of other malignancies or treatment-related masses. Safety parameters are evaluated during the 42-day follow-up, while long-term survival and disease progression are monitored every six months for at least five years. The study will conclude when all participants have completed five years of combined treatment and follow-up.

Researchers are evaluating Pumitamig compared to Durvalumab in adults with unresectable stage III Non-small Cell Lung Cancer NSCLC who have completed concurrent chemoradiation therapy. This phase 3 study aims to assess which treatment better controls cancer progression and improves survival outcomes in this patient population. Participants are randomly assigned to receive either Pumitamig or Durvalumab at specified doses on designated days. Both treatments are administered following at least two cycles of platinum-based concurrent chemoradiotherapy with a radiation dose of at least 54 Gy. The study focuses on patients who have no progressive disease after this initial treatment and have good performance status. Throughout the trial, participants will be monitored for progression-free survival and other outcomes such as overall survival, objective response, disease control rate, and duration of response over several years. Assessments include imaging reviewed by independent central reviewers and investigators according to standardized criteria. The study involves regular evaluations to track cancer status and safety, with follow-up extending up to approximately nine years to understand long-term effects.