Sandton

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating sacituzumab tirumotecan alone and combined with pembrolizumab compared to the treatment chosen by a physician for people with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on participants whose cancer has progressed despite prior endocrine therapy, including treatment with a CDK4/6 inhibitor. The main goal is to see if these treatments improve progression-free survival, which means the length of time the cancer does not worsen, over up to approximately 38 months. Participants receive sacituzumab tirumotecan as an intravenous infusion, either alone or combined with intravenous pembrolizumab. The comparison group receives the treatment of physician's choice, which may include intravenous paclitaxel, nab-paclitaxel, liposomal doxorubicin, or oral capecitabine. The study is open-label and randomized, meaning participants are assigned to different treatment groups openly. Treatments are administered according to the study protocols, with ongoing monitoring during the treatment period. Throughout the study, participants are monitored regularly to assess their cancer status and overall health. This includes evaluations by blinded independent central review using RECIST 1.1 criteria to measure tumor progression. Researchers also assess safety, organ function, and performance status. The total participation time may last up to around 38 months to track progression-free survival and other outcomes. Careful monitoring helps ensure participant safety and collects data on treatment effectiveness and side effects.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

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.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.