Federal District

This research aims to evaluate the effectiveness and safety of a combination of three drugsinavolisib, ribociclib, and fulvestrantcompared to a placebo combined with ribociclib and fulvestrant. It focuses on people with advanced breast cancer that is resistant to endocrine therapy, specifically those with hormone receptor-positive, HER2-negative disease who have certain genetic markers related to chromosome 8p loss and no PIK3CA mutation. The study is conducted as a phase II, randomized, double-blind, placebo-controlled trial to explore treatment options in this patient group. Participants are randomly assigned to receive either inavolisib along with ribociclib and fulvestrant or a placebo with ribociclib and fulvestrant. Each drug is given according to a specific schedule outlined in the study protocol, though exact dosing details are not provided here. This setup allows researchers to compare the results and safety profiles of the combination treatment against the placebo combination over the course of the study. Throughout the trial, participants undergo regular assessments to measure treatment response, including the percentage of participants with confirmed objective response, progression-free survival, overall survival, duration of response, and clinical benefit rate. The study also tracks adverse events and patient-reported side effects using validated questionnaires. These evaluations may continue for up to approximately two years, ensuring thorough monitoring of both effectiveness and safety during the participants involvement.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor CDK46i and letrozole compared to placebo plus CDK46i and letrozole in adults with endocrine-sensitive PIK3CA-mutated hormone receptor-positive HR, HER2-negative advanced breast cancer. This phase III, randomized, double-blind study focuses on participants who have measurable disease and meet specific hormone receptor and HER2 status criteria. Participants are randomly assigned to receive either oral inavolisib once daily along with letrozole and CDK46i or placebo once daily with letrozole and CDK46i. The CDK46i is given on a schedule of either Days 1-21 or Days 1-28 of each 28-day cycle. The study includes parallel groups to compare these treatment combinations over time. During the study, participants will be monitored for progression-free survival, overall survival, response rates, duration of response, clinical benefit, and changes in pain, physical function, and global health status. Safety will be assessed by tracking adverse events and patient-reported treatment side effects using questionnaires. The study will follow participants for up to seven years, with regular evaluations to track disease status and quality of life.

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are studying the safety and effectiveness of NNC0487-0111 for adults with excess body weight and type 2 diabetes. This Phase 3 clinical trial compares NNC0487-0111 with a placebo to see how well the medicine helps reduce body weight when taken along with diet and exercise changes. Participants have type 2 diabetes for at least six months and meet specific health criteria to join the study. Participants are randomly assigned to receive one of four different doses of NNC0487-0111 or a placebo. Each treatment is given as a weekly injection under the skin using a pre-filled pen injector, targeting areas like the thigh, abdomen, or upper arm. All participants follow a reduced-calorie diet and increase physical activity during the study. The main treatment period lasts 84 weeks, with body weight and other health measures tracked throughout. During the study, participants will have regular assessments including blood tests to check blood sugar levels, cholesterol, and other health markers. Researchers will also monitor waist size, blood pressure, and quality of life related to physical function. Safety is carefully watched by tracking any side effects or adverse events until 88 weeks. Overall, participants are involved in frequent visits and health evaluations to measure treatment impact and safety over nearly two years.