Homburg

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

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 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). The study is observational, conducted in Germany, and aims to compare how long patients stay on each treatment under real-world conditions according to local labels and standard care. About 678 participants will be enrolled across approximately 80 sites in Germany. Participants will have been prescribed UPA or TNFi independently of the study, following approved labels and local regulations. The study will observe participants receiving either UPA or TNFi therapy over a period of up to 24 months. Participants will be followed for up to 24 months to assess treatment retention. Researchers will monitor how long participants remain on their prescribed treatment and collect related clinical data. The total study duration, including recruitment and follow-up, is expected to last about 48 months.

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 the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

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 ELVN-001, a new drug, in adults with chronic myeloid leukemia (CML), including those with or without a specific T315I mutation. This early phase 1a/1b study aims to find the best dose of ELVN-001 for future studies by assessing its safety, tolerability, and how the body processes the drug. The study also looks at changes in a key leukemia marker called BCR-ABL1 to gather initial evidence of the drug's effect on CML. Participants will receive ELVN-001 orally once or twice daily. The trial includes a dose escalation period to identify recommended doses for further research. This first-in-human study will monitor patients closely to understand the safety profile and pharmacokinetics of ELVN-001. The drug is being tested in patients who have relapsed, are resistant, or cannot tolerate other tyrosine kinase inhibitors (TKIs). Throughout the study, participants will be monitored for adverse events, dose-limiting toxicities, and any significant lab or heart test abnormalities up to 28 days in phase 1a and for up to 3 years in phase 1b. Researchers will assess safety, tolerability, and leukemia markers regularly. The total duration of monitoring allows for a thorough evaluation of ELVN-001's effects and safety in adults with chronic phase CML.

Researchers are investigating the effects of multiple doses of vosoritide and comparing its therapeutic dose to human growth hormone (hGH) in children with idiopathic short stature (ISS). This Phase 2 study aims to understand how these treatments influence growth in this population. After an initial observation period of at least 6 months to measure baseline growth, participants are randomly assigned to receive either vosoritide, placebo, or hGH (the latter only in the United States). Those in the vosoritide and placebo groups undergo up to 6 months of randomized treatment, followed by open-label vosoritide until they reach near-final adult height or at least age 16 for females or 18 for males. Participants assigned to hGH receive open-label treatment for a minimum of 4 years. Throughout the study, safety is carefully monitored with clinical and imaging assessments focused on hips and lower extremities, as well as watching for hypotension, fractures, and slipped capital femoral epiphysis. An independent Data Monitoring Committee reviews safety data regularly. Study visits include a treatment completion visit about 4 weeks after the last dose, and follow-up assessments may continue annually through the end of the study. Key outcome measures include changes in annualized growth velocity at 6 months and changes in height and height Z-score after 4 years.