Velbert

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

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 observational study follows patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study is non-interventional and open-label, designed to collect real-world data on treatment and disease progression over several years. It aims to understand how patients continue their baseline treatments and how these treatments impact various health and quality of life measures. Participants receive routine medical care with approved injectable or oral DMTs such as ofatumumab, interferon b21, glatiramer acetate, teriflunomide, dimethyl fumarate, or diroximel fumarate. The study includes two cohorts with up to approximately two years of prospective observation each, with an optional extension allowing up to four years total. Treatment decisions and monitoring follow the patients usual care and physicians discretion, including routine visits and telemedicine options. During the study, participants provide medical history, complete questionnaires, and have data collected on disability status, MRI findings, relapses, and laboratory tests. Researchers assess treatment continuation rates, fatigue, anxiety, depression, quality of life, lesion counts, and relapse rates at multiple time points. Safety and treatment interruptions are also documented. Follow-up is flexible and based on standard care procedures, with data collection occurring throughout the observational periods.

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are studying the effectiveness of neladalkib NVL-655 compared to alectinib in patients with advanced Non-Small Cell Lung Cancer NSCLC that tests positive for Anaplastic Lymphoma Kinase ALK and who have not received prior treatment. This Phase 3 trial aims to determine if neladalkib can better prolong the time patients live without disease progression. The study involves patients with advanced or metastatic ALK-positive NSCLC and is sponsored by Nuvalent Inc. Participants will be randomly assigned to one of two groups one group will take neladalkib 150 mg orally once daily, and the other will take alectinib 600 mg orally twice daily. Both treatments are given as oral pills, and the study compares these two drugs directly. Patients will be followed for up to 5 years after starting treatment to assess outcomes. During the trial, patients will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, brain imaging to monitor intracranial progression, and laboratory tests. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, adverse events, and patient-reported quality of life and lung cancer symptoms. The study will last until December 2029, with close follow-up to evaluate long-term effects and safety.

Researchers are evaluating palazestrant OP-1250 compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK46 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.

Researchers are evaluating the safety and effectiveness of datopotamab deruxtecan Dato-DXd compared with docetaxel in patients with advanced or metastatic non-squamous non-small cell lung cancer NSCLC that tests positive for trophoblast cell surface protein 2 TROP2 but lacks actionable genomic alterations. This phase III, randomized, open-label study also aims to assess the clinical performance of an investigational diagnostic test related to TROP2 expression. Participants will be randomly assigned to receive either Dato-DXd or docetaxel as an intravenous infusion every three weeks. Each treatment is given on Day 1 of a 21-day cycle. The study includes two groups one receiving Dato-DXd monotherapy and the other receiving docetaxel monotherapy. The study will continue until disease progression or other discontinuation criteria are met. Throughout the study, participants will undergo regular assessments to measure progression-free survival and overall survival over approximately 2.5 to 3.5 years. Additional evaluations include response rates, duration of response, symptom assessments, quality of life questionnaires, and biomarker analyses. Safety monitoring and diagnostic testing will also be conducted. The total participation time will depend on individual treatment duration and follow-up requirements.