Penzberg

Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

The trial investigates the effectiveness, safety, and patients' quality of life when using additive chemotherapy after surgery or ablation in patients with metastatic colorectal cancer. This phase III, open-label, randomized, controlled, multicenter study compares two groups: one receiving chemotherapy and the other undergoing active follow-up without additional treatment. All patients have had their metastatic lesions definitively treated before joining the trial. Participants in the chemotherapy group receive up to six months of treatment with either mFOLFOXIRI or mFOLFOX-6, with up to 12 cycles administered every two weeks. The other group undergoes active surveillance without further chemotherapy. The study includes regular tumor biopsies at screening and upon relapse if possible, aiming to study tumor and blood markers. Imaging scans such as CT or MRI of the chest and abdomen are performed every three months during the first two years, then every six months thereafter, with follow-up continuing for up to five years. Throughout the study, patients are monitored every three months with radiologic assessments, blood tests, and quality of life questionnaires. Researchers aim to detect any cancer relapse through imaging and blood markers and evaluate progression-free survival over 24 months. Safety and clinical status are regularly assessed, and structured follow-up is maintained for both groups up to 60 months after randomization.