Velbert

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 various approved injectable and oral disease-modifying treatments (DMTs) in patients with relapsing multiple sclerosis (RMS) in Germany. This observational, non-interventional, multicenter, open-label study collects primary data prospectively over up to four years, alongside retrospective data. The study captures medical history, disease duration, laboratory values, disability scores (EDSS), MRI results, and relapse information to provide real-world insights into treatment use and outcomes. Patients receiving routine medical treatment with any approved injectable or selected oral DMTs—including ofatumumab, glatiramer acetate, interferon 21, teriflunomide, dimethyl fumarate, and diroximel fumarate—are enrolled without treatment allocation by the study. Two cohorts are observed: one treated primarily with injectable DMTs and another with injectable or oral DMTs. The core study period lasts about two years, with an optional extension providing an additional two years of observation, totaling up to four years. Follow-up visits and monitoring happen at the investigator's discretion and may include telemedicine. During the study, participants provide data through questionnaires and electronic case report forms. Routine clinical care procedures, such as diagnostic tests and monitoring, continue as usual. Researchers measure the proportion of patients continuing their baseline treatment at 24 months and collect ongoing clinical and imaging data. The study emphasizes real-world treatment patterns, safety, and disease activity over the extended follow-up period.

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

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.

Migraine is a neurological condition causing moderate to severe headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. This research aims to assess how well atogepant works in adults with migraine when used in everyday medical practice. Atogepant is an approved preventive treatment for migraines, and the study will include about 1000 adult participants prescribed this medication by their doctors worldwide. Participants will take atogepant tablets orally as prescribed by their healthcare providers following usual medical care. The study will observe participants over a two-year period without requiring extra treatments or procedures beyond their regular clinical visits. These visits will occur at hospitals or clinics according to each participant's routine care schedule. During the study, participants will attend regular check-ups where researchers will monitor their health and migraine symptoms. The main outcome measured will be the percentage of participants who report feeling "much better" or "very much better" by week 12, based on their own impression of change. There are no additional burdens expected for participants beyond their normal treatment and follow-up appointments.

Researchers are evaluating the safety and effectiveness of palazestrant (OP-1250) compared to standard treatments fulvestrant or an aromatase inhibitor in adults with ER-positive, HER2-negative advanced or metastatic breast cancer. Participants have previously received endocrine therapy combined with a CDK4/6 inhibitor, and their cancer has progressed despite this treatment. This phase 3, international, randomized, open-label trial aims to provide new information on treatment options for this population. Participants will be assigned to receive either palazestrant daily in a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or standard endocrine therapy with fulvestrant or one of three aromatase inhibitors (anastrozole, letrozole, or exemestane), given according to their approved schedules. After selecting the optimal palazestrant dose, more participants will be randomized to receive either that dose or standard care. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for adverse events, dose reductions, or treatment discontinuation for up to 16 weeks after randomization. The main outcome is progression-free survival, measured until disease progression or death, with an estimated follow-up of up to 2 years. Assessments will include physical exams, lab tests, and regular evaluations of cancer status and side effects to ensure safety and track the effectiveness of the treatments.

Researchers are evaluating the effectiveness and safety 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 TROP2 but does not have actionable genomic alterations. This phase III, randomized, open-label, multicenter study also assesses the performance of a new diagnostic device to identify suitable participants. Eligible patients have previously been treated for their cancer and meet specific genomic and disease progression criteria. Participants will receive either datopotamab deruxtecan or docetaxel, both given through intravenous (IV) infusions. The study has two arms comparing these treatments directly. Treatment and monitoring will continue according to the study protocol. The investigational drug, Dato-DXd, is being closely evaluated against the standard chemotherapy drug docetaxel for its impact on disease control. During the study, participants will undergo various assessments including imaging scans to measure tumor response and disease progression. Researchers will monitor progression-free survival over approximately 2.5 years and overall survival over about 3.5 years. Other evaluations include performance status, laboratory tests, and safety monitoring to track side effects and overall health throughout the study period.

Researchers are evaluating the effectiveness and safety of combining ribociclib with standard adjuvant endocrine therapy (ET) in patients with hormone receptor-positive (HR+), HER2-negative early breast cancer. This study focuses on patients with Anatomic Stage Group III, IIB, and certain cases of Stage IIA breast cancer. It is a phase IIIb, open-label, multicenter, single-arm trial aiming to measure invasive breast cancer-free survival over three years. Participants who complete screening will receive ribociclib at 400 mg orally once daily for 21 days followed by 7 days off, in 28-day cycles, alongside daily endocrine therapy for 36 months, roughly 39 cycles. Endocrine therapies may include letrozole, anastrozole, exemestane, or hormone-suppressing drugs like goserelin or leuprolide, administered as per standard dosing schedules. After treatment, there is a 30-day safety follow-up and a longer follow-up period lasting until death, withdrawal, loss to follow-up, or up to 48 months after the last participant's first dose. During the study, participants will be monitored for safety and treatment efficacy through regular assessments including heart monitoring via ECG, performance status checks, and laboratory tests to ensure organ function. The main outcome is the rate of invasive breast cancer-free survival at three years. Safety follow-up calls occur 30 days after the last treatment dose, and participants are followed long-term to observe any disease recurrence or other health outcomes.