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Researchers are studying oligodendrogliomas, a type of brain tumor identified by specific genetic changes such as IDH1 or IDH2 mutations and 1p/19q co-deletion. These tumors are classified as CNS WHO grade 2 or 3, and the study aims to determine the best treatment approach to improve survival while preserving brain function and quality of life. This phase 3 trial compares current standard treatments because existing data is unclear about the best timing and combination of chemotherapy and radiotherapy for these tumors. The study compares two treatment approaches for adults with newly diagnosed grade 2 or 3 oligodendrogliomas. One group receives an initial chemotherapy regimen of lomustine and temozolomide (CETEG) with delayed radiotherapy plus PCV chemotherapy at progression. The other group receives standard radiotherapy followed by PCV chemotherapy. Radiotherapy doses vary based on tumor grade. The study plans to assess if delaying radiotherapy and adjusting chemotherapy can maintain survival while reducing side effects. Participants will undergo regular monitoring including MRI scans every three months, neurological assessments, quality of life questionnaires, and annual cognitive testing. Researchers will measure qualified overall survival, defined as survival without decline in function, cognition, or quality of life. The study will last up to 10 years, with close tracking of side effects, tumor response, and patients' well-being to determine the best balance of treatment effectiveness and quality of life.

Researchers are conducting an international multicenter retrospective observational study to better understand the progression and clinical outcomes in patients with Essential Thrombocythemia (ET) who have the JAK2V617F mutation and later develop Polycythemia Vera (PV). The study follows updated 2022 diagnostic criteria for these myeloid blood disorders and includes two parts: a nested case-control study and a comparative retrospective cohort study. In the first part, patients who progressed from ET to PV by the end of 2020 are matched 1:1 with ET patients who have the same mutation but did not progress, based on year and age at ET diagnosis and disease duration. The second part compares patients with newly diagnosed PV who never had ET, matched similarly by year and age at diagnosis and disease duration, ensuring at least 5 years of follow-up for these patients. Participants' medical records will be reviewed retrospectively to compare clinical features and outcomes up to their baseline dates. The study aims to clarify phenotypic changes and clinical results in these patient groups. No interventions are administered, and the study focuses on analyzing existing data to assess progression and outcomes in these blood conditions.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

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 effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) compared to treatment chosen by physicians for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The study aims to find out if I-DXd can improve the objective response rate, meaning the proportion of patients whose cancer shrinks or disappears, and extend overall survival time compared to other treatments. Secondary goals include assessing safety, patient-reported outcomes, immune response to I-DXd, B7-H3 protein levels, and how the drug is processed in the body. Participants will receive either I-DXd at a dose of 12 mg/kg given intravenously on the first day of each 21-day treatment cycle or one of the physician's choice treatments including Topotecan, Amrubicin, or Lurbinectedin, administered according to local standards of care. The study is randomized and open-label, meaning treatments are assigned by chance and both patients and doctors know which treatment is given. During the study, participants will be closely monitored with tumor assessments to evaluate response and detect disease progression, safety evaluations, and quality of life questionnaires. The main outcomes measured are the objective response rate assessed by a blinded independent review and overall survival time, tracked for up to approximately five years after randomization. Researchers will also monitor for any adverse effects and collect health economics data to understand the broader impact of treatments.

This research aims to evaluate the safety and effectiveness of belimumab in adults with interstitial lung disease (ILD) related to connective tissue diseases (CTDs) such as rheumatoid arthritis, lupus, and others. ILD causes lung inflammation and stiffness, reducing lung volume and leading to symptoms like shortness of breath, cough, and fatigue, significantly affecting quality of life and being a leading cause of death in these patients. The study focuses on whether adding belimumab to standard therapy can stabilize or improve lung function and relieve ILD symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both administered as a subcutaneous injection alongside their standard treatment. The study is a phase 3, double-blind, placebo-controlled trial designed to compare these two groups over time. Belimumab treatment is given under careful monitoring to assess its impact on lung disease progression. Throughout the study, participants will undergo assessments including lung function tests, specifically measuring forced vital capacity (FVC) at the start and after 52 weeks. Researchers will monitor changes in lung capacity to determine treatment effects. Participants will be evaluated for safety and symptom changes, with ongoing review of their ability to manage their condition. The total duration includes regular follow-ups and assessments to understand the long-term impact of the treatment.

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease (SSc-ILD). This Phase 2/3 randomized, double-blind study aims to assess how belimumab affects lung function and other disease symptoms such as skin thickening and fatigue, which impact quality of life. Participants will receive either belimumab or placebo administered subcutaneously. The study focuses on those diagnosed with diffuse cutaneous systemic sclerosis and active or progressive disease. Treatment is given under blinded conditions, and participants must be capable of self-administering the medication or have a caregiver to assist. During the study, lung function will be monitored by measuring changes in forced vital capacity (FVC) from baseline to Week 52. Researchers will also assess skin involvement and general symptoms. Safety and tolerability will be closely followed throughout the trial, which includes screening and regular assessments to evaluate treatment effects and participant well-being.