Jena

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

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 safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

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.