Bebington

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the effectiveness of combining autogene cevumeran with nivolumab compared to nivolumab alone as adjuvant treatment for participants with high-risk muscle-invasive urothelial carcinoma (MIUC). The study is a Phase II, randomized, double-blind, multicenter trial aiming to assess disease-free survival and safety in this patient group. This study includes participants who have undergone surgical removal of MIUC and may have received prior treatments such as neoadjuvant chemotherapy or checkpoint inhibitors. The study begins with a safety run-in phase where participants receive both autogene cevumeran and nivolumab to monitor safety. After this phase, additional participants will be randomized to receive either autogene cevumeran plus nivolumab or saline plus nivolumab. All treatments are administered via intravenous infusion according to the specified schedules. The study compares the two treatment approaches to evaluate their impact on preventing cancer recurrence. Participants will be closely monitored throughout the study, with assessments including imaging scans to confirm absence of disease, biomarker analyses from tumor tissue, and regular safety evaluations. The primary outcome measure is investigator-assessed disease-free survival, tracked from randomization until recurrence or death, over approximately six years. Participants' recovery status and overall health will be evaluated throughout the study to ensure safety and treatment adherence.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents aged 12 years and older who have a kidney condition known as focal segmental glomerulosclerosis (FSGS). This Phase 3 study aims to understand whether BI 764198 can improve kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants by comparing changes in urine protein levels over 104 weeks. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, and the other group takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual FSGS treatments during the study, which lasts up to two years. During the study, participants visit the study site approximately every three months. They regularly provide urine samples to monitor kidney function, and doctors check their overall health and note any side effects. The main outcome measured is the change in the 24-hour urine protein-to-creatinine ratio from the start of the study to week 104, helping researchers understand the treatment's impact on kidney disease.

Researchers are evaluating the anti-cancer effects of inobrodib combined with pomalidomide and dexamethasone in patients with multiple myeloma that has returned after treatment and no longer responds to available therapies. This Phase II, open-label, multicenter study focuses on patients who have relapsed or refractory multiple myeloma and have previously been treated with proteosome inhibitors, anti-CD38 monoclonal antibodies, pomalidomide, and bispecific T-cell engagers. The study also aims to better understand the side effects of inobrodib when used with these other medications. About 100 patients will receive 20 mg of inobrodib orally twice daily for 4 days followed by 3 days off in each 28-day cycle. Pomalidomide will be taken at 4 mg orally once daily from Day 1 to Day 21 of each cycle, and dexamethasone will be taken at 40 mg orally once daily on Days 1, 8, 15, and 22 of each cycle. Treatment continues until the disease progresses, unacceptable side effects occur, a new cancer treatment starts, or withdrawal criteria are met. Participants will be regularly monitored to assess the objective response rate, which is the percentage of patients whose disease improves according to standard criteria, until disease progression or death for up to 48 months. Researchers will also evaluate safety and side effects throughout the study. Assessments include physical exams, lab tests, and review of medical status to ensure treatment compliance and participant well-being during the study period.

Researchers are evaluating the effectiveness and safety of puxitatug samrotecan compared to the physician's choice of chemotherapy in women with advanced or metastatic endometrial cancer that expresses the B7-H4 marker. These participants have had cancer progression after treatment with platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapies. This Phase III global, open-label study aims to determine whether puxitatug samrotecan can help participants live longer without their cancer worsening or simply live longer overall, while also assessing the impact on quality of life. Participants will be randomly assigned to one of two treatment groups. One group will receive puxitatug samrotecan given by intravenous infusion at a dose of 2.4 mg/kg on Day 1 every three weeks. The other group will receive the physician's choice of chemotherapy: either doxorubicin given intravenously at 60 mg/m2 on Day 1 every three weeks, or paclitaxel given intravenously at 80 mg/m2 on Days 1, 8, and 15 in a 28-day cycle. The study plans to enroll about 700 eligible participants worldwide. During the study, participants will undergo regular assessments to monitor their cancer progression and overall survival for approximately three years. Researchers will evaluate tumor measurements using imaging and assess participants' quality of life. Safety will be closely monitored throughout the treatment period, and participants' health status will be followed to determine the effects of the treatments over time.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and biological activity of CCS1477 (inobrodib) in patients with advanced blood cancers including Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, and Peripheral T-cell lymphoma. This Phase 1/2a study aims to assess CCS1477 alone and in combination with other treatments in patients who have relapsed or refractory hematological malignancies and have received prior standard therapy. The study involves administering CCS1477 as an oral capsule, either by itself or combined with several other drugs such as Pomalidomide, Dexamethasone, Azacitidine, Venetoclax, Bortezomib, Ixazomib, Elranatamab, Teclistamab, Lenalidomide, and Daratumumab. These treatments are given in various oral or injectable forms. The study is open-label, allowing researchers to monitor safety and efficacy during the treatment period. Participants will be closely monitored for treatment-related side effects and laboratory abnormalities for up to 12 months. Evaluations include regular assessments of organ function, performance status, and any adverse events. Researchers will track the incidence of side effects and lab test changes to understand the safety profile of CCS1477 and its combinations. The total participation duration includes the treatment and follow-up phases to ensure thorough safety and efficacy data collection.