Belgorod

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the safety and effectiveness of a single bolus dose of non-immunogenic recombinant staphylokinase compared to a placebo in adults with intermediate high-risk pulmonary embolism PE who have stable blood pressure. This phase 3 trial addresses the need for safer thrombolytic treatments in patients who are at risk but do not have shock or low blood pressure, as previous thrombolytics had risks like hemorrhagic stroke. The study aims to improve outcomes while minimizing adverse effects in this patient group. Participants receive either a quick intravenous injection of non-immunogenic recombinant staphylokinase or a matching placebo. The staphylokinase dose is 15 mg given as a single bolus over 10-15 seconds regardless of body weight. The placebo group receives a similar injection with saline solution. This treatment period is followed by monitoring to compare the effects and safety between the two groups. During the study, participants will be assessed for clinical outcomes including death, hemodynamic collapse, and recurrent pulmonary embolism within 30 days. Additional measures include heart function and lung pressure evaluations within 24 hours and 30 days, along with monitoring for bleeding events and other adverse effects. The trial lasts for 30 days after treatment with ongoing safety checks, and participant consent and adherence to contraceptive use are required throughout the study period.

This research aims to study the safety and effectiveness of a drug called non-immunogenic staphylokinase in patients with massive pulmonary embolism, a serious condition involving blood clots in the lungs. The study builds on previous trials that found this drug to be as effective as alteplase with fewer major bleeding events, making it a promising emergency treatment option. The study is observational and focuses on patients receiving this drug in routine clinical practice. Participants receive a single intravenous bolus dose of 15 mg non-immunogenic staphylokinase Fortelyzin4 regardless of body weight. This drug is easy to administer quickly in emergency situations and is used for treating massive pulmonary embolism since 2024. The study collects information on patients treated with this drug to assess outcomes in a real-world setting. During the study, participants are monitored for outcomes such as all-cause mortality at 7 and 30 days after drug administration, hemodynamic collapse, recurrent pulmonary embolism, and pulmonary artery systolic pressure changes. Safety is closely observed, especially for bleeding events. The study runs from June 2025 to December 2027, with ongoing evaluation of participants following treatment in routine care.