Kempten Allgau

Researchers are evaluating the real-world effectiveness, safety, and patient compliance 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 ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

Researchers are investigating whether adding intismeran autogene to pembrolizumab after surgery helps people with non-small cell lung cancer NSCLC stay cancer-free longer compared to pembrolizumab with a placebo. This study focuses on participants whose tumors did not fully respond to treatment before surgery. It is a phase 3 trial aiming to evaluate treatment options for resectable stage II to IIIB N2 NSCLC patients who did not achieve a complete pathological response after neoadjuvant therapy. Participants receive neoadjuvant treatment with pembrolizumab and chemotherapy drugs such as cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel, given by intravenous infusion every three weeks for up to four cycles. After surgery, participants receive adjuvant treatment with pembrolizumab every six weeks combined with either intismeran autogene or placebo by intramuscular injection every three weeks, for up to seven and nine doses respectively. During the study, participants undergo treatment cycles, surgery, and follow-up assessments. Researchers evaluate disease-free survival over approximately 97 months and monitor overall survival, metastasis-free survival, quality of life, physical and role functioning, and adverse events up to around 129 months. The study includes regular evaluations and safety monitoring to understand the impact of these treatments on long-term outcomes and participant well-being.

Researchers are evaluating the real-world effectiveness of asciminib in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase Ph CML-CP. This observational study compares patients who are newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor TKI to those treated with other TKIs. The study aims to assess tolerability, safety, and molecular response outcomes in routine clinical care. Participants are grouped into cohorts based on their treatment those receiving asciminib, those newly diagnosed treated with imatinib, and those newly diagnosed treated with second-generation TKIs such as dasatinib, bosutinib, or nilotinib. Treatment decisions are made by physicians prior to enrollment, and treatment must not have started more than 14 days before joining the study. The study follows patients over time to document treatment patterns, dose changes, interruptions, and discontinuations. Participants will attend routine follow-up visits and complete patient-reported outcome questionnaires assessing medication adherence, quality of life, and work productivity at multiple time points up to 24 months. Researchers will measure major molecular response at 12 months as the primary outcome and evaluate various secondary molecular responses, reasons for treatment changes, and quality of life scores. The study duration extends through September 2030, allowing long-term observation of treatment effectiveness and safety.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are evaluating the real-world use of neoadjuvant nivolumab combined with platinum-based chemotherapy in adults with early-stage, resectable non-metastatic non-small cell lung cancer NSCLC. This observational study aims to assess how effective this combination treatment is in routine clinical practice across Germany, led by Bristol-Myers Squibb. Participants receive three cycles of neoadjuvant nivolumab along with platinum-based chemotherapy before surgery, following current approved guidelines. The study observes these treatments as given independently of the study, without altering usual care. During the study, researchers collect detailed information including tumor response, surgical outcomes, patient health status, adverse events, and quality of life measures. Follow-up lasts up to five years to monitor event-free survival and other long-term outcomes. Participants complete questionnaires and undergo regular medical assessments and imaging as part of this comprehensive data collection.

This research aims to compare two surgical methods for treating large abdominal wall defects, including ventral and incisional hernias. The trial evaluates whether the minimally-invasive, robotically-assisted ventral hernia repair RVHR offers better outcomes than the traditional open ventral hernia repair OVHR. The study focuses on key results such as length of hospital stay after surgery, complication rates, recurrence, reoperations, and quality of life. Participants will undergo either the RVHR or OVHR procedure. The RVHR involves using robotic assistance to place trocars and perform detailed dissection and mesh placement with absorbable sutures. The OVHR is an open surgery with a median laparotomy, adhesiolysis as needed, and mesh placement with optional fixation methods. Both procedures include closure of the abdominal wall layers and dressings designed to keep the study blinded. After surgery, participants will be followed up through in-person visits or remotely via phone or email at day 7, day 30, 6 months, and then at 1, 3, and 5 years. Evaluations include measuring the length of hospital stay, complications, pain, functional recovery, and quality of life using the SF-12 form. Safety and outcomes are monitored during this period to assess the differences between the two surgical methods.

Researchers are conducting a prospective registry study to observe and document the treatment and disease progression in patients with recurrent and metastatic prostate cancer. The study includes four distinct patient groups based on disease status those with biochemical recurrence after local treatment, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is enrolled and followed independently over different time periods to understand the course of therapy and disease. The study does not prescribe any specific treatment but records routine care as decided by each patients physician. Data collection occurs during routine clinical visits at set intervals, including after enrollment, every 3 to 6 months, and when therapy changes occur. Standardized quality of life questionnaires FACT-P and EQ-5D-5L are completed, and biological samples are collected to support comprehensive assessment. Participants are followed long-term, with an average follow-up of seven years. Researchers document therapy patterns, disease management strategies, imaging assessments, patient-reported outcomes, treatment adherence, and adverse events throughout this period. The focus is on real-world data reflecting everyday clinical practice, enabling a detailed understanding of treatment effectiveness and disease progression in prostate cancer patients.