Alcabideche

Researchers are evaluating rilvegostomig compared with pembrolizumab monotherapy as a first-line treatment for people with metastatic non-small cell lung cancer mNSCLC whose tumors have high PD-L1 expression. This Phase III, global, randomized, and double-blind study aims to assess the efficacy and safety of these treatments in this patient population. The trial is sponsored by AstraZeneca and focuses on patients with specific tumor characteristics and no certain genetic mutations. Participants will receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study has two treatment arms one for the investigational drug rilvegostomig and one for the active comparator pembrolizumab. Both treatments are given as monotherapy to understand their effects as initial therapy in this cancer setting. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately 5 years. Additional assessments include tumor response, duration of response, time to second progression or death, drug pharmacokinetics, immunogenicity, and patient-reported outcomes related to physical function, quality of life, and lung cancer symptoms. The study involves regular evaluations to track treatment effects and safety over an extended period.

Researchers are evaluating the effects of pelacarsen TQJ230, given as a monthly subcutaneous injection, on slowing the progression of calcific aortic valve stenosis in adults aged 50 to under 80 years with elevated Lipoproteina levels. This phase 2, randomized, double-blind, placebo-controlled multicenter trial aims to assess the efficacy, safety, and tolerability of pelacarsen compared to a matching placebo. The study is sponsored by Novartis Pharmaceuticals and focuses on patients with mild to moderate calcific aortic valve stenosis who are optimally treated for cardiovascular risk factors. Participants receive either pelacarsen 80 mg or a placebo via a prefilled syringe injected under the skin once every month. The study includes two groups one receiving the active drug and the other receiving a placebo, both administered in the same way. The trial will last up to 36 months, during which patients will be monitored for changes in aortic valve function and calcium levels. Throughout the study, participants will undergo evaluations including measurement of peak aortic jet velocity and aortic valve calcium scores at 36 months. Additional assessments include changes in Lipoproteina levels at 12 months and monitoring of fibrocalcific thickening of the valve and clinical events over the course of the trial. Safety will be closely monitored to ensure participants well-being during the entire study period.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy HRT compared to alternative treatments, abiraterone acetate or enzalutamide, in adults with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat improves the time participants live without their cancer worsening on scans, considering both those with and without certain androgen receptor mutations. Overall survival was also added as a secondary outcome to be assessed over a longer period. Participants are randomly assigned to one of two treatment groups. One group receives oral opevesostat twice daily along with daily dexamethasone and fludrocortisone acetate, continuing until their disease progresses. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone acetate plus prednisone or enzalutamide daily, also until disease progression. The study is open-label, meaning both researchers and participants know which treatment is given. During the study, participants will have regular assessments including imaging scans to monitor cancer progression, blood tests, and questionnaires evaluating quality of life and symptoms. Researchers will track the time until cancer worsens on imaging, overall survival, response rates, pain progression, and side effects. These evaluations may continue for up to approximately 82 months. Safety monitoring and treatment adherence will be followed throughout the study period.

This research aims to evaluate whether motor imagery training combined with brain-computer interface BCI and virtual reality VR can improve arm and hand recovery after stroke. The trial focuses on understanding if adding immersive VR to BCI training enhances upper limb movement, daily activity performance, and brain activity related to movement. Researchers will compare this combined approach to standard motor imagery with BCI to assess any added benefits for stroke survivors. Participants will undergo two separate intervention periods in random order one involving motor imagery-based BCI training with immersive VR and multimodal feedback, and the other using motor imagery-based BCI with a cue-based visual protocol. Each intervention consists of three weekly sessions over six weeks, with a three-week gap between periods. Both training types use EEG-based BCI control, while the VR sessions involve an immersive headset and haptic controllers providing visual, auditory, and touch feedback. During the study, participants will complete four assessment sessionsbefore and after each intervention periodto measure changes in upper limb motor function and activity using clinical tests. Brain activity will be monitored through EEG during all intervention sessions to assess neural changes. The total study duration for each participant is up to 15 weeks, including both interventions and the washout period. Researchers will also explore participant experiences and individual factors influencing outcomes.

This research aims to observe the use of trastuzumab deruxtecan T-DXd in adults with HER2-low unresectable or metastatic breast cancer who have previously received chemotherapy in the metastatic setting or experienced disease recurrence within 6 months after adjuvant chemotherapy. The study will collect information on patient characteristics, how treatments are used, tolerability, management of side effects, and patient experiences with T-DXd, as well as data on conventional chemotherapy treatments in a registry. Participants will receive T-DXd or conventional chemotherapy as chosen by their doctors according to approved guidelines in routine clinical practice. No study drug is given by the research team since this is a non-interventional study. The conventional chemotherapy group will be analyzed separately to better understand treatment patterns and outcomes. During the study, researchers will gather data for up to 31 months, monitoring real-world time to next treatment, treatment patterns, safety events, use of treatments to manage side effects, and patient-reported outcomes including tolerability and quality of life. They will also track occurrences of nausea and vomiting through patient diaries. This information will help evaluate treatment use and patient experiences outside of clinical trial settings.

Researchers are evaluating neladalkib NVL-655 compared to alectinib for patients with advanced Anaplastic Lymphoma Kinase ALK positive Non-Small Cell Lung Cancer NSCLC who have not yet received treatment. This Phase 3, multicenter, randomized, controlled, open-label study aims to see if neladalkib can better prolong progression-free survival PFS than alectinib in this patient group. Participants will be randomly assigned in equal numbers to receive either neladalkib or alectinib. Neladalkib is taken as a 150 mg oral tablet once daily, while alectinib is taken as a 600 mg oral capsule twice daily. The study includes up to 5 years of follow-up to assess outcomes and compare the two treatments. During the study, participants will undergo regular evaluations including imaging to measure disease progression, laboratory tests, and assessments of symptoms and quality of life. Researchers will monitor progression-free survival as the primary outcome, along with overall survival, response rates, intracranial progression, and treatment side effects. Patient-reported measures on lung cancer symptoms, functioning, and quality of life will also be collected throughout the follow-up period.

Researchers are evaluating treatments for advanced breast cancer that is hormone receptor-positive HR-positive and HER2-low or ultralow, specifically in patients classified as non-luminal subtype by gene expression profiling PAM50. This phase II, international, multicenter, randomized trial aims to compare the effectiveness and safety of trastuzumab deruxtecan T-DXd versus a physicians choice of CDK46 inhibitor CDK46i combined with endocrine therapy ET as first-line treatments for these patients. Participants will be randomly assigned to receive either T-DXd at a dose of 5.4 mgkg administered intravenously on Day 1 of each 21-day cycle or a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib chosen by their physician along with endocrine therapy fulvestrant, letrozole, anastrozole, or exemestane. Treatment continues until disease progression or unacceptable side effects. The study specifically includes patients with unresectable locally recurrent or metastatic breast cancer with non-luminal subtype confirmed by central PAM50 analysis. During the study, participants will undergo regular evaluations including imaging tests like CT or MRI to assess disease status and progression-free survival, which is the primary outcome measured for up to 25 months. Secondary outcomes include overall survival, response rates, duration of response, quality of life assessments, and monitoring of adverse events. Patients will be closely monitored for treatment effects and side effects, with follow-up planned to track health outcomes and treatment response throughout the study period.