Hiram

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Heart disease is a leading cause of death across many groups in the United States. Researchers are evaluating if screening and early treatment of mild heart disease can improve outcomes. This trial focuses on adults at low 10-year heart disease risk who have risk factors, aiming to detect early plaque buildup in heart arteries using specialized CT scans. The study includes two parts a screening phase using Coronary Artery Calcium CAC scans and Coronary CT Angiography CCTA to identify plaque, followed by a treatment trial for about 1,500 participants. Those with certain plaque levels may be randomly assigned to receive either placebo or medicationsrosuvastatin a cholesterol-lowering drug and colchicine an anti-inflammatory drugin various combinations taken once daily. Participants also receive advice on heart-healthy lifestyle changes and an mHealth program to support behavior modification. Participants undergo up to two in-person visits during screening and several virtual visits during the treatment phase over two years, including blood collection at home and CCTA scans at baseline and study end. The main goal is to measure changes in non-calcified plaque volume in arteries over two years. Safety, treatment adherence, and various plaque-related outcomes will also be monitored throughout the study.