Riverhead

Researchers are evaluating a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

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.

This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.

This research aims to optimize treatment for patients with Heart Failure NYHA Class III who have reduced ejection fraction LVEF less than 35%. It evaluates the use of BaroStim, a device implanted after CardioMems insertion, to monitor and manage pulmonary artery diastolic pressure and other heart function markers. The study is sponsored by Northwell Health and follows patients over an extended period to assess changes in heart health and function. Patients who qualify for both CardioMems and BaroStim devices will first receive the CardioMems implant and undergo 3 months of medication management and optimization. Following this, BaroStim will be implanted and titrated during office visits, with ongoing monitoring of pulmonary artery pressures, blood pressure, and exercise capacity. The goal is to maintain pulmonary artery diastolic pressure at 18-20 mm Hg or less. The study includes a 1-year follow-up after BaroStim insertion to track heart function and symptoms. Participants will attend regular in-office visits for device adjustment and measurements, including the 6-minute walk test, vital signs, and laboratory tests such as NT-pro BNP levels. Researchers will observe changes in heart failure classification, medication use, and hospitalizations over the study period. Continuous monitoring of pulmonary artery diastolic pressure via CardioMems will help assess the impact of BaroStim. The total participation time extends through at least one year following BaroStim implantation.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved alternative therapies available. This Phase 3, multicenter, randomized, open-label study compares a new combination treatment called the Bria-IMT regimen plus a checkpoint inhibitor Retifanlimab against treatment chosen by patients and their physicians. The study also aims to assess the effectiveness of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. The study includes three initial groups one receiving Bria-IMT plus Retifanlimab, one receiving physicians choice treatment such as eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine, or taxanes, and one receiving Bria-IMT alone. After enrolling 150 patients, the Bria-IMT alone group will be stopped, and those patients may switch to the combination therapy. Treatment cycles for Bria-IMT arms occur every three weeks, with imaging assessments every six weeks twice, then every eight weeks if no disease progression or safety concerns arise. Participants will undergo various assessments throughout the study, including imaging and clinical evaluations, to track overall survival up to 60 months. Secondary outcomes include progression-free survival, clinical benefit rate, overall response rate, quality of life, and central nervous system event-free survival. Safety and treatment effects will be monitored continuously, and participants may be followed for up to five years after starting treatment.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.