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Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

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 study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating a new atrioventricular interval modulation AVIM algorithm designed for dual-chamber Medtronic AstraAzure pacemakers. This multinational, randomized, double-blind clinical trial aims to assess the safety and effectiveness of this AVIM therapy in patients with hypertension who either have or are scheduled to receive these pacemakers. The study is led by Orchestra BioMed, Inc and focuses on managing high blood pressure through this innovative device approach. The trial includes three phases a screening phase, a one-year double-blind randomized phase, and a two-year unblinded phase. Participants who meet eligibility criteria will have the investigational AVIM therapy software downloaded into their AstraAzure pacemaker. They will be randomly assigned to either have the AVIM therapy activated along with their stable antihypertensive drug treatment or have the AVIM therapy deactivated while continuing their usual drug therapy. Participants will be monitored over the course of the study, with the main outcomes measured including changes in 24-hour ambulatory systolic blood pressure at three months and the occurrence of any unanticipated serious adverse device effects. Throughout the study, subjects will continue their antihypertensive medications and undergo regular assessments to evaluate blood pressure control and device safety. The total study duration extends up to five years, allowing for long-term follow-up and evaluation.

Researchers are evaluating the safety and effectiveness of TORL-1-23 in women with advanced platinum-resistant epithelial ovarian cancer, including primary peritoneal and fallopian tube cancers that express Claudin 6. This Phase 2 study focuses on patients whose cancer has not responded well to platinum-based chemotherapy and aims to understand how this treatment works in this population. The study involves three groups receiving different doses of TORL-1-23 given as an intravenous infusion on Day 1 of every 21-day cycle. Alongside TORL-1-23, participants receive pegfilgrastim by subcutaneous injection on Day 4 of each cycle to support their immune system. Each treatment cycle lasts three weeks, and all participants follow this schedule throughout the study period. Participants will be monitored regularly with scans and lab tests to measure how their cancer responds to treatment, including progression-free survival and overall survival. Safety will be checked by recording side effects and laboratory abnormalities from the start of treatment until 30 days after the last dose. The study will last about 40 months, during which disease progression and other outcomes will be tracked at set intervals to assess the treatments effects.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer IRONMAN as a prospective, global group of at least 5,000 men with advanced prostate cancer, including those with metastatic hormone-sensitive prostate cancer mHSPC and metastatic castration-resistant prostate cancer M0M1 CRPC. This study aims to better understand variations in care and treatment across different countries and medical settings by collecting detailed patient data over time. Participants will receive standard care drugs routinely used for metastatic prostate cancer based on local practices. Data collection begins at enrollment and continues for at least five years. Blood samples and tumor tissue, when possible, will be collected at enrollment, treatment changes, and follow-ups to study molecular markers linked to treatment response and resistance. Patient-reported outcome measures PROMs will be gathered every three months, and physicians will provide treatment and follow-up information regularly. During the study, participants will provide health and treatment information through questionnaires, with regular monitoring of survival, adverse events, and comorbidities. Blood samples will support future research to identify biomarkers. The main outcome is observing practice patterns over five years to help improve understanding of treatment sequences that optimize survival and quality of life for men with advanced prostate cancer.

This research aims to observe patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation who are undergoing treatment with the PulseSelect PFA System. The study is a prospective, global, multi-center, non-randomized observational trial designed to monitor outcomes after ablation using this approved device. The trial focuses on evaluating freedom from atrial fibrillation at 36 months post-procedure and safety regarding device or procedure-related adverse events at 6 months. Participants will receive ablation treatment with the commercially available PulseSelect PFA System according to standard hospital care. The study includes follow-up visits at 3, 6, 12, 24, and 36 months after ablation. During the 6, 12, 24, and 36 month visits, participants will undergo 24-hour Holter monitoring to track heart rhythm and other relevant cardiac data. Throughout the 36-month follow-up period, participants will attend scheduled study visits for evaluations including heart rhythm monitoring and safety assessments. Researchers will measure treatment effectiveness by assessing freedom from atrial fibrillation and monitor for any device or procedure-related adverse events. The study involves long-term observation to understand outcomes after treatment with the PulseSelect PFA System.

Researchers are studying Rina-S, a drug designed to target folate receptor alpha, in people with advanced solid tumors that have either spread or cannot be removed by surgery. This Phase 12 trial aims to evaluate the safety, how the drug behaves in the body, and its antitumor activity. The study includes several parts focusing on specific cancers such as ovarian, endometrial, breast, lung cancers, mesothelioma, and cervical cancer, reflecting different patient groups and treatment approaches. Participants may receive Rina-S alone or combined with other drugs like carboplatin, bevacizumab, or pembrolizumab. Treatment continues until disease progression, unacceptable side effects, or other reasons such as withdrawal or study end. The study involves multiple cohorts, including those with platinum-resistant or platinum-sensitive ovarian cancer and endometrial cancer, with dosing and combination therapies tailored to these groups. During the trial, participants undergo regular assessments including imaging scans evaluated by standardized criteria, safety monitoring for side effects, and blood tests to study drug levels and immune responses. Outcomes measured include treatment side effects, tumor response rates, progression-free and overall survival, and pharmacokinetics. Participants may be followed for up to approximately two years to evaluate long-term effects and treatment responses.