Speyer

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of a medicine called NNC0487-0111 for adults with excess body weight, specifically targeting obesity. This Phase 3 clinical study aims to see if this treatment helps people maintain their weight loss compared to a placebo, which contains no active medicine. Participants are randomly assigned to either the treatment or placebo group to fairly compare results. The study involves two groups receiving weekly injections under the skin: one group gets NNC0487-0111, and the other receives a placebo designed to look the same. The treatment is given once a week, and participants reach a target dose during an initial run-in period before the main study phase begins. During the study, researchers track changes in body weight from week 40 to week 92 to assess how well the treatment works. Participants' safety and health are monitored throughout the study, including various medical assessments. The total participation time covers these weeks and includes ongoing observation to understand the treatment's effects over time.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are investigating the use of ribociclib combined with standard endocrine therapy as a first-line treatment for women with advanced hormone receptor positive (HR+) and human epidermal growth factor receptor negative (HER2-) breast cancer. This phase IV, open-label, single-arm study aims to evaluate the progression-free survival (PFS) and overall survival (OS) rates at 12 months, along with quality of life, treatment toxicity, and comprehensive biomarker analysis to understand patterns of treatment efficacy and resistance. Participants will receive ribociclib orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off, in 28-day cycles, combined with standard endocrine therapy according to current guidelines and local practice. The study includes extensive biomarker sampling before, during, and after treatment or at disease progression, including blood, tissue, and immune cell analyses to support translational research. During the trial, patients will attend scheduled visits for monitoring and assessments including survival status, safety evaluations, and quality of life questionnaires. Biomarker samples such as circulating tumor DNA and RNA, serum, plasma, and tumor tissue will be collected to evaluate biological changes. The trial plans to enroll 1000 female patients across 75 sites in Germany, with comprehensive follow-up to track treatment outcomes and long-term safety.

Researchers are collecting long-term follow-up data on patients with multiple myeloma who took part in therapy studies conducted by the German-Speaking Myeloma Multicenter Group (GMMG). This observational registry study aims to track important outcomes such as overall survival, progression-free survival, and follow-up duration to support scientific research. The registry combines data from previous trials with ongoing patient information for comprehensive analysis. The GMMG Myeloma Registry is a national, observational, and non-interventional study that includes both past and ongoing patient data. It incorporates study databases from various GMMG trials, including the phase 3 GMMG-HD6 trial, which evaluated adding the monoclonal antibody elotuzumab to standard therapy for newly diagnosed multiple myeloma patients eligible for transplant. Data is collected from 35 centers across Germany, with no limit on sample size. Participants will be followed during their standard care treatment until death, loss to follow-up, or withdrawal of consent. Follow-up visits occur every six months until the first disease progression and then yearly afterward. Clinical data is securely stored and regularly monitored with automated checks to ensure accuracy. The main outcome tracked is progression-free survival after five years and through the study's completion, averaging one additional year of observation.

Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation (ASCT). This phase III clinical trial compares a maintenance treatment combining iberdomide and isatuximab with iberdomide alone. The main goal is to see if adding isatuximab reduces the amount of myeloma cells in the bone marrow after two years. Participants are randomly assigned to one of two groups. One group receives 39 cycles of oral iberdomide, each cycle lasting 29 days. The other group receives the same iberdomide treatment plus subcutaneous isatuximab injections given on specific days during the first three cycles and then monthly from cycle four onward. Both groups receive dexamethasone during the first cycle. The study treatment continues for up to 36 months. During the study, participants undergo regular assessments including bone marrow tests to measure minimal residual disease, blood tests, and questionnaires to evaluate quality of life. Researchers monitor disease progression, response to treatment, and survival over time. The primary outcome is the level of minimal residual disease in the bone marrow 24 months after starting maintenance therapy. Secondary outcomes include progression-free survival, overall survival, response rates, and patient-reported quality of life measures.

Researchers are evaluating a medicine called elranatamab for the treatment of multiple myeloma (MM), a type of cancer. This study focuses on people aged 18 or older who have MM that has returned or not responded to previous treatments, including prior use of an anti-CD38 antibody and lenalidomide. The goal is to compare elranatamab to other common combination therapies that include 2 to 3 different MM medicines. This is a Phase 3 study to learn about the safety and effectiveness of elranatamab compared to these other treatments. Participants will be randomly assigned to receive either elranatamab or a combination therapy selected by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, which may later reduce in frequency. The combination therapy options include medicines taken by mouth and given either as shots under the skin or through a needle in the vein at the clinic. The combination medicines used may be elotuzumab, pomalidomide, dexamethasone, bortezomib, or carfilzomib, depending on the chosen treatment plan. Participants may continue their assigned treatment until their MM stops responding. During the study, participants will visit the clinic regularly for monitoring and evaluation. Researchers will track how well the treatments work by measuring progression-free survival and will watch for any side effects or safety concerns. Follow-up will continue after treatment ends through phone calls or visits. The study may last up to about 5 years to fully assess the outcomes of the treatments.

Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.

Researchers are evaluating the real-world clinical use and outcomes of men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with a combination of olaparib and abiraterone. The study focuses on patients who have either not previously received next-generation hormonal agents (NHA-naive) or who have been exposed to NHAs before starting this combined treatment. This prospective observational study aims to describe patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone therapy. The study will enroll patients who have started treatment with olaparib plus abiraterone after the study site became active. It will follow patients for up to 2 years to collect data on their treatment experience. No experimental interventions are administered as part of the study; instead, it observes patients receiving standard treatment in routine clinical settings. Participants will be monitored from the start of olaparib treatment until one year after the last patient enrolls. Researchers will collect clinical data to assess treatment discontinuation times and overall outcomes during this period. The study will capture information on patients’ clinical progress and any subsequent therapies, providing insights into the real-world effectiveness and use of this treatment combination.