Wenatchee

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

This research focuses on adults with obesity or overweight and aims to evaluate the safety and effectiveness of various investigational treatments for chronic weight management. It is a Phase 2 master protocol study that uses a framework to test multiple interventions, each detailed in separate appendices. The study establishes criteria for enrolling new participants and reports results when all intervention appendices have completed. Participants may receive different investigational drugs administered either by subcutaneous injection or orally, including LY3305677, LY3841136, tirzepatide, LY3549492, and others. Each intervention-specific appendix outlines the particular treatment details and analyses. Some participants receive placebos matching the administration method of the active treatments. Treatments and analyses are conducted in parallel groups, and interventions may start independently as they become available. Throughout the study, participants undergo screening to confirm eligibility and are randomly assigned to one of the intervention groups or placebo. Researchers monitor participant allocation up to week 6. The trial emphasizes double-blind procedures, and participant involvement includes receiving study treatments and attending scheduled visits. Safety and efficacy data are collected, and the study is planned to continue until early 2028, with primary outcome measures focusing on participant allocation to interventions.

Researchers are evaluating the safety, immune response, and preliminary clinical efficacy of a candidate vaccine for urinary tract infections UTIs in adults aged 18 to 64 years. This trial focuses on adults generally for safety and immune response, and specifically on females with a history of at least one confirmed E. coli UTI within the past year for clinical efficacy. The study includes two parts an initial dose-escalation safety phase and a proof-of-principle efficacy phase, designed to establish the highest tolerated dose and evaluate the vaccines impact on UTI occurrence. Participants receive one of several vaccine dose formulations or placebo administered by injection on Day 1 and Day 61. Part 1 involves healthy male and female adults and tests increasing antigen doses for safety. After safety review, Part 2 enrolls females with previous E. coli UTIs to assess vaccine efficacy compared to placebo over a 12-month period. The vaccine is given intramuscularly following a 0 and 2 months schedule. Throughout the study, participants are monitored for side effects at the injection site and systemic reactions during the first week after each dose, as well as for any adverse events up to 426 days from the first dose. Blood tests, pregnancy monitoring, and clinical exams are conducted. The main outcome measures include the frequency of adverse events and the rate of urine culture confirmed UTIs in females during the follow-up period. Participants are followed closely for safety and immune response, with the trial lasting over a year from initial vaccination.

Researchers are evaluating the efficacy and safety of ifinatamab deruxtecan I-DXd in adults with various recurrent or metastatic solid tumors. These tumor types include endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinoma of the esophagus, gastroesophageal junction and stomach, urothelial carcinoma, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low and HER2 IHC 0 breast cancer, cutaneous melanoma, and neuroendocrine carcinoma. The study includes multiple phases to assess treatment effects and safety in these diverse groups. Participants receive I-DXd via intravenous infusion, typically dosed at 12 milligrams per kilogram, except in hepatocellular carcinoma where the dose is determined separately. The study is divided into three parts Stage 1, Stage 2, and an optional Stage 3 expansion for endometrial cancer, depending on safety and efficacy results. Each participant starts at Stage 1 and may continue to Stage 2 based on observed data. The hepatocellular carcinoma group includes a safety run-in phase to evaluate tolerability. Participants engage in regular assessments including imaging scans to measure tumor response and disease progression. Researchers monitor treatment-related side effects and collect blood samples to study how the drug behaves in the body over time. The studys main goal is to measure the objective response rate up to about 60 months after the first dose. Safety evaluations continue during treatment and for 47 days after the last dose. Participants may remain in the study for up to five years to track long-term outcomes and overall survival.

Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on body weight reduction in adults with obesity or overweight who do not have type 2 diabetes. This Phase 2b clinical trial aims to study the weight-lowering effectiveness and safety of these drugs compared with placebo under a randomized, double-blind, placebo-controlled design. Participants are assigned to one of several groups receiving macupatide, eloralintide, both drugs together, or placebo, all administered by subcutaneous injection. The study lasts about 64 weeks, including treatment and follow-up periods, with dosing at different levels and combinations to assess the interventions effects on weight management. During the study, participants undergo regular visits for assessments including body weight measurements up to at least week 36 and beyond. Researchers monitor changes in body weight, body mass index BMI, and the proportion of participants who achieve significant weight loss percentages. Safety and adherence are also tracked throughout the trial to evaluate the treatments over the full participation period.

Researchers are evaluating a new medicine called Risvutatug Rezetecan also known as GSK5764227 or Ris-Rez in people worldwide who have advanced gastrointestinal cancers that cannot be removed by surgery. These participants have previously received treatment for their cancer. The study aims to understand how well this medicine works, how safe it is, and how the body processes it. Participants will receive Risvutatug Rezetecan alone or combined with other drugs, including Drug 1, Drug 2, Drug 3, and Drug 4. The study includes different dosing groups and combinations to assess the medicines effects. Treatments will be given according to the assigned group, and the study follows a randomized design without masking. During the trial, participants will undergo regular assessments including scans and laboratory tests to monitor cancer response and safety. Researchers will measure outcomes such as tumor response rate, duration of response, progression-free survival, and changes in vital signs and blood tests. The study will also track side effects and how the medicine is processed by the body over up to approximately 37 months. Participants will be closely monitored throughout the study period, which lasts several years.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

This research aims to assess the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with rilvegostomig or rilvegostomig alone compared to pembrolizumab alone as initial treatment in participants with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has high PD-L1 expression tumor cells 50% and no actionable genetic alterations. This Phase III, randomized, open-label global study focuses on patients who have not received previous systemic therapy for advanced disease. Participants are randomly assigned to one of three groups one group receives Dato-DXd plus rilvegostomig, another receives rilvegostomig alone, and the third receives pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study evaluates these treatments as first-line therapy for eligible participants. During the study, participants will have regular assessments including tumor evaluations and biomarker testing to monitor disease progression, overall survival, and response rates. Patient-reported symptoms and quality of life will also be measured. The study may last up to approximately six years to capture long-term outcomes. Safety monitoring and pharmacokinetics assessments are included throughout the trial to understand treatment effects and immune responses.

This research aims to observe patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation who are undergoing treatment with the PulseSelect PFA System. The study is a prospective, global, multi-center, non-randomized observational trial designed to monitor outcomes after ablation using this approved device. The trial focuses on evaluating freedom from atrial fibrillation at 36 months post-procedure and safety regarding device or procedure-related adverse events at 6 months. Participants will receive ablation treatment with the commercially available PulseSelect PFA System according to standard hospital care. The study includes follow-up visits at 3, 6, 12, 24, and 36 months after ablation. During the 6, 12, 24, and 36 month visits, participants will undergo 24-hour Holter monitoring to track heart rhythm and other relevant cardiac data. Throughout the 36-month follow-up period, participants will attend scheduled study visits for evaluations including heart rhythm monitoring and safety assessments. Researchers will measure treatment effectiveness by assessing freedom from atrial fibrillation and monitor for any device or procedure-related adverse events. The study involves long-term observation to understand outcomes after treatment with the PulseSelect PFA System.