Alcabideche

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Stroke often causes long-term disability, especially affecting arm and hand function, which impacts independence and quality of life. This research aims to evaluate whether training sessions using motor imagery combined with brain-computer interface (BCI) and virtual reality (VR) can improve arm and hand recovery after stroke. The study compares this combined MI-VR-BCI approach with motor imagery and standard BCI (MI-BCI) alone to see if adding VR helps improve upper limb movement, daily activities, and brain activity related to movement. Participants will take part in two intervention periods in random order: one with MI-VR-BCI and one with MI-BCI. Each period involves training sessions three times per week for six weeks, separated by a three-week break. The MI-VR-BCI uses an immersive VR headset and haptic controllers to provide visual, auditory, and touch feedback during motor imagery tasks, while the MI-BCI uses a cue-based visual system without VR. Throughout the study, participants will complete four assessment sessions, one before and one after each intervention period. Researchers will measure changes in upper limb motor function and activity using clinical tests, as well as brain activity and connectivity using EEG during the sessions. The total study duration includes up to 15 weeks, accounting for interventions and washout periods, with detailed monitoring of clinical and neurophysiological outcomes.

Researchers are evaluating neladalkib (NVL-655) compared to alectinib in patients with treatment-naefve, ALK-positive advanced Non-Small Cell Lung Cancer (NSCLC). This Phase 3, multicenter, randomized, controlled, open-label study aims to show that neladalkib can prolong progression-free survival (PFS) better than alectinib in this patient group. Patients included have advanced or metastatic NSCLC confirmed to have ALK rearrangement and have not received prior systemic anticancer treatments for NSCLC. Participants will be randomly assigned in a 1:1 ratio to receive either oral neladalkib tablets or oral alectinib capsules. Each group will have approximately 225 patients. Treatment will be given as first-line therapy without prior ALK tyrosine kinase inhibitor use. The study monitors the patients over time to compare the effectiveness of these two drugs in controlling the disease. During the study, researchers will assess progression-free survival up to 5 years after the first patient is dosed, using blinded independent central review. Patients will have measurable disease and provide pretreatment tumor tissue for evaluation. Safety monitoring includes tracking heart rhythm, infections, and other health conditions. The study excludes patients with certain infections, recent major surgery, or other active cancers requiring therapy. This comprehensive follow-up aims to evaluate how well each treatment controls cancer progression and its safety over time.

This is an international, multicenter, two-arm, randomized, phase II clinical trial for patients with unresectable locally recurrent or metastatic HR-positive and HER2-low/ultralow breast cancer classified as non-luminal by gene expression profiling. Female or male patients ≥ 18 years of age with HR-positive and HER2-low/ultralow locally recurrent inoperable or metastatic breast cancer classified as non-luminal subtype by central PAM50 analysis will be enrolled. Patients will be randomized to T-DXd 5.4 mg/kg body weight administered as an IV infusion on Day 1 of each 21-day cycle or physician's choice of CDK4/6 inhibitor plus endocrine therapy. The main objective of the study is to demonstrate that first-line T-DXd compared with CDK4/6i plus ET is superior in prolonging the progression free survival (PFS) based on investigator assessment in patients with HR-positive, HER2-low advanced breast cancer classified as non-luminal by central PAM50 analysis (HER2-low population) and all patients.