Penzberg

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.