Kempten Allgau

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.

This research aims to compare intismeran autogene combined with pembrolizumab versus placebo with pembrolizumab as an additional treatment after surgery for people with stage II, IIIA, or IIIB (with nodal involvement) non-small cell lung cancer (NSCLC) that has been fully removed with clear margins. The study is a phase 3 trial investigating whether the combination including intismeran autogene improves disease-free survival compared to the placebo combination. Participants will receive either intismeran autogene by intramuscular injection plus pembrolizumab by intravenous infusion or a placebo injection plus pembrolizumab. The treatments are given after surgery and standard platinum-based chemotherapy. No more than 24 weeks can pass from surgery to the first pembrolizumab dose. The study evaluates these treatments as adjuvant therapy to reduce cancer recurrence. During the trial, researchers will monitor participants for disease-free survival for up to approximately 78 months. Participants undergo regular assessments including medical evaluations to track cancer status and treatment effects. The study excludes those with prior neoadjuvant therapy, certain infections, or other cancer treatments that might interfere. Safety and long-term outcomes are carefully observed throughout the study period.

Researchers are evaluating whether adding intismeran autogene to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) remain cancer-free longer compared to pembrolizumab with a placebo. This study focuses on patients with NSCLC whose tumors did not completely respond to treatment before surgery and aims to prevent the cancer from returning. It is a Phase 3 randomized, double-blind study involving participants with resectable Stage II to IIIB (N2) NSCLC. Participants receive treatments including pembrolizumab given as an intravenous infusion and either intismeran autogene or placebo administered as an intramuscular injection. Before surgery, patients have received neoadjuvant pembrolizumab combined with platinum-based doublet chemotherapy, but only those who did not achieve a complete pathological response are eligible. The study compares the effects of pembrolizumab with or without intismeran autogene following surgery. During the study, participants are closely monitored for disease-free survival over a period of up to approximately 97 months. Researchers will assess whether the cancer returns and evaluate overall safety. Participants undergo regular evaluations including clinical assessments and laboratory tests to monitor their health and treatment response throughout the study period.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

Researchers are collecting and analyzing real-world data to understand how well neoadjuvant nivolumab combined with platinum-based chemotherapy works in people with early-stage, operable non-small cell lung cancer (NSCLC) in Germany. This observational study focuses on patients whose cancer has not spread and who have a tumor PD-L1 expression level of 1% or higher, as approved in the European Union. Participants receive neoadjuvant treatment with nivolumab alongside platinum-based chemotherapy following current medical guidelines. The treatment involves three cycles of this combination before surgery to remove the lung cancer. The study is conducted across multiple centers in Germany, following the standard use of these drugs as described in their official product information. During the study, participants will complete patient-reported outcome questionnaires and be monitored for up to five years to measure event-free survival, meaning the length of time without cancer recurrence or progression. Safety and effectiveness data will be gathered from medical records and routine clinical assessments. The total participation time aligns with the treatment cycles and long-term follow-up to track outcomes over several years.

Researchers are evaluating the safety and effectiveness of two different radiation treatments for patients with larger brain metastases measuring 2 to 4 cm. This Phase III, prospective, multicenter randomized trial compares fractionated stereotactic radiotherapy with single session radiosurgery to understand which approach offers better local control and fewer side effects. Patients with cerebral metastases from solid cancers are the focus of this study, which stratifies participants based on tumor volume and cancer histology. Participants will be randomly assigned to receive either fractionated stereotactic radiotherapy, given as 12 treatments of 4 Gy each with a 2 mm margin, or single session radiosurgery. Radiosurgery dosing depends on tumor size: 18 Gy for metastases 2-3 cm in size, or 15 Gy for those 3-4 cm, following RTOG 9005 guidelines. The study carefully monitors and compares these two radiation approaches to determine their impact on tumor control and side effects. During the study, participants will be followed for at least 12 months to measure the time to local progression of their brain metastases. Researchers will perform clinical evaluations, imaging scans such as contrast-enhanced MRI, and monitor side effects to assess treatment outcomes. The study ensures patient safety by excluding those with contraindications to MRI or prior overlapping radiation treatments. Overall, the trial aims to provide detailed information about treatment effectiveness and safety for patients with larger brain metastases.

Researchers are evaluating the treatment and disease progression in men with recurrent or metastatic prostate cancer through a long-term registry study. The study includes patients with four distinct prostate cancer conditions: biochemical recurrence after surgery or radiation, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is studied independently during different time periods to better understand their treatment courses and disease outcomes. There is no specific treatment assigned by the study. Instead, patients receive care according to the usual medical practice at their treatment centers. Treatments may vary and are decided by each patient's doctor. Data is collected at routine visits after enrollment, then every 3 or 6 months, and whenever therapy changes. This includes recording treatments, disease status, quality of life questionnaires (FACT-P and EQ-5D-5L), and collection of biomaterial. Participants will be involved in regular follow-up visits where their disease progression and therapy details are documented. The study monitors therapy frequencies and patterns for an average of 7 years. Researchers assess these long-term outcomes along with quality of life and other clinical data to better understand prostate cancer management in real-world settings.