Erfurt

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after previous therapy. This study compares the effects of two oral drug combinations belzutifan plus zanzalintinib versus cabozantinib. The aim is to find out if the combination of belzutifan and zanzalintinib helps patients live longer overall and delays cancer progression compared to cabozantinib alone. Participants in this study will be randomly assigned to one of two groups. One group will take belzutifan and zanzalintinib orally once daily, while the other group will take cabozantinib orally once daily. Treatment will continue until certain conditions require stopping. This is an open-label, phase 3 trial evaluating these treatments in people with advanced RCC who have had disease recurrence during or after prior anti-PD-1L1 therapy. During the study, participants will be monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also track response rates, duration of response, side effects, and quality of life using questionnaires over about 25 months. Safety assessments and regular evaluations will be performed as part of the study. Total study participation may last several years, depending on individual circumstances and treatment continuation.

Researchers are evaluating the retention rates of two treatments, upadacitinib UPA and tumor necrosis factor inhibitors TNFi, in adults with moderate to severe active rheumatoid arthritis RA in a real-world setting in Germany. This observational study aims to compare how long patients stay on each treatment when prescribed according to local standards and labels. About 678 participants will be enrolled over approximately 24 months, with total study duration lasting up to 48 months. Participants will receive either upadacitinib or a TNFi treatment as prescribed by their physicians following local regulatory and reimbursement guidelines. The decision to treat with UPA or TNFi is made independently of the study and before recruitment. The study does not assign treatments but observes patients already prescribed these therapies. During the study, researchers will monitor participants for up to 24 months to measure retention rates of the treatments. Data collection will include regular assessments according to routine care practices to track treatment persistence. The study focuses on real-world outcomes without altering standard treatment or care. Safety monitoring and follow-up will be conducted as part of usual medical care.

This research aims to observe patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study collects data to understand how these treatments are used in routine care and their effects over time. It is an observational, non-interventional, multicenter, open-label study sponsored by Novartis Pharmaceuticals. Patients will be followed in two cohorts Cohort 1 includes patients starting or recently started on injectable DMTs, and Cohort 2 includes patients starting or recently started on either ofatumumab or other approved injectable or oral DMTs. The core observational period is up to two years, with an optional extension adding another two years, totaling up to about four years of observation. Treatment decisions are made independently by patients and their physicians, and no study-mandated treatment or monitoring is imposed. Participants will provide data through questionnaires and electronic case report forms, with medical history including disease duration, lab values, MRI results, and relapse information collected. Routine clinical care assessments and telemedicine visits may occur at the investigators discretion. The study measures include treatment continuation rates, disability scores, relapse rates, quality of life, fatigue, anxiety, depression, MRI lesion monitoring, and safety events, with follow-up visits scheduled as per standard care over the study period.

Researchers are conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light sNfL as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis MS. The study focuses on patients who have received category 1 disease-modifying therapies DMTs and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physicians clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.

Researchers are studying the real-world effectiveness, safety, and patient experience 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 patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are evaluating the safety and performance of the MOBYBOX System, an extracorporeal cardiopulmonary support device, in patients experiencing cardiac, respiratory, or combined cardiorespiratory failure. The study aims to gather prospective data on how well the device works and its safety profile in real-world use for patients with severe conditions affecting heart and lung function. The MOBYBOX System is used in two configurations veno-arterial for cardiac or cardiorespiratory failure and veno-venous for severe respiratory failure. The device provides extracorporeal support to help patients whose heart or lungs are failing. The study monitors device performance every 4 hours while patients are receiving extracorporeal membrane oxygenation ECMO with the MOBYBOX system and records serious adverse events within 24 hours. Participants will be closely observed during their treatment with the device, with assessments focusing on safety by tracking serious adverse events within 24 hours and mortality within 30 days. Device performance success is also recorded regularly during treatment. The study will continue to follow patients until December 2026, collecting data relevant to the devices safety and effectiveness in supporting heart and lung function in critically ill patients.

Researchers are studying whether ziltivekimab can help people living with heart failure and inflammation. The trial focuses on participants with heart failure who have mild to preserved heart function and systemic inflammation. This phase 3 study compares ziltivekimab, a new medicine not yet approved, to an inactive placebo to understand its effects on heart failure symptoms and physical function. Participants will receive either ziltivekimab or a matching placebo administered as a subcutaneous injection once a month for 12 months. Both groups will continue their standard heart failure care alongside the study treatment. The treatment assignment is randomized, meaning participants have an equal chance of receiving the active medicine or placebo, and the study uses a quadruple masking method to keep participants and researchers unaware of the treatment given. During the study, participants will be monitored for changes in heart failure symptoms using tools like the Kansas City Cardiomyopathy Questionnaire and a 6-minute walk test. Researchers will also assess inflammation markers, heart function measures, and quality of life at regular intervals over the 12 months. The study aims to observe the effects of ziltivekimab compared to placebo over this period, with safety and symptom improvement carefully tracked.

Researchers are evaluating the addition of LY3537982 olomorasib to standard anti-cancer treatments in people with advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene mutation. The study aims to see if combining LY3537982 with pembrolizumab, with or without chemotherapy, is more effective than standard care. This phase 3 trial includes participants with untreated advanced NSCLC and can last up to three years, depending on individual progress. Participants may receive different combinations of treatments in 21-day cycles, including LY3537982 taken orally with pembrolizumab given intravenously, sometimes combined with chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin. Some groups receive placebo pills instead of LY3537982. The study has multiple parts including dose optimization, safety lead-in, and randomized treatment phases. Participants can continue treatment until specific discontinuation criteria are met. During the trial, participants will undergo regular assessments for side effects and disease progression through scans and clinical evaluations. Researchers will measure progression-free survival, overall survival, response rates, and physical function, as well as lung cancer symptoms using questionnaires. Safety monitoring and quality-of-life assessments will continue during treatment and follow-up periods. The study collects data for up to three years to evaluate the treatments impact.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan I-DXd compared with treatments chosen by physicians for adults with relapsed extensive-stage small cell lung cancer SCLC. This Phase 3 randomized study aims to see if I-DXd can improve objective response rates and prolong overall survival compared to other standard treatments. The study also examines other factors such as patient-reported outcomes, immunogenicity, B7-H3 protein expression, and pharmacokinetics of I-DXd. Participants are randomly assigned to one of two groups. One group receives I-DXd at a dose of 12 mgkg intravenously on Day 1 of each 21-day cycle until unacceptable side effects, disease progression, or withdrawal. The other group receives one of three treatmentstopotecan, lurbinectedin, or amrubicinbased on the doctors choice and local guidelines, continuing until treatment criteria for stopping are met. No placebo is used, and the study is open-label. During the study, participants will have tumor assessments and survival monitored up to about five years. Evaluations include measuring tumor response by independent review and investigators, progression-free survival, duration of response, quality of life questionnaires, safety monitoring for adverse events, and tests of drug levels in the blood. Participants will be followed for disease progression, treatment effects, and survival throughout the study period, which may last several years.

Researchers are investigating the efficacy and safety of golcadomide combined with rituximab compared to investigators choice treatments in adults with relapsed or refractory follicular lymphoma who have received at least one prior systemic therapy. This multicenter, randomized, open-label Phase 3 study focuses on participants with confirmed follicular lymphoma that has returned or not responded to previous treatments, aiming to better understand treatment options in this setting. Participants will be randomly assigned to receive either golcadomide plus rituximab or one of the investigators chosen regimens, which may include rituximab combined with lenalidomide, R-CHOP chemotherapy rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisoneprednisolone, or rituximab with bendamustine. Each treatment involves specified doses on specified days, and the study compares these approaches over a treatment period. During the study, participants will be closely monitored through evaluations such as imaging scans, pathology reviews, and quality of life questionnaires. Researchers will assess progression-free survival up to approximately 32 months, along with other measures like overall response rate, overall survival, duration of response, and minimal residual disease status. Safety and treatment effects will be tracked, and participants may be followed for up to nearly seven years to gather comprehensive outcome data.