Telford

Researchers are evaluating new treatments for advanced renal cell carcinoma RCC, a type of kidney cancer. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, against belzutifan with a placebo. The goal is to see if the combination can help people live longer and prevent the cancer from getting worse after other treatments have failed. Participants will take 120 mg of belzutifan orally and either 60 mg of zanzalintinib or a matching placebo once daily for about 24 months. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active combination or placebo. Two groups are compared belzutifan plus zanzalintinib and belzutifan plus placebo. During the study, participants will be monitored for progression-free survival and overall survival, with assessments up to around 30 to 50 months. Researchers will also evaluate tumor response, duration of response, quality of life, and side effects. Safety and tolerability will be tracked throughout treatment and follow-up periods. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide important information on treating advanced RCC.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are evaluating the effects of ersodetug as an additional treatment to standard care for patients who have Tumor Hyperinsulinism Tumor HI, a condition causing low blood sugar due to hormone overproduction by certain tumors that cannot be removed or treated satisfactorily with current therapies. This Phase 3 study aims to assess the blood sugar control, safety, and tolerability of ersodetug in this patient group. Participants will receive weekly doses of ersodetug at 9 mgkg for 8 weeks alongside their usual hypoglycemia treatments. The study is organized into three parts a screening period lasting up to 4 weeks, an 8-week treatment phase, and either an end-of-study follow-up period of up to 20 weeks or an optional open-label extension lasting up to 3 years. Approximately 16 participants diagnosed with tumor HI will take part across several international study sites. During the study, participants will be monitored for changes in their need for intravenous glucose, including the main outcome of whether their glucose infusion rate decreases meaningfully after 8 weeks. Researchers will also track other measures such as total daily glucose delivery and the time needed to stop IV glucose after starting ersodetug. Safety assessments and follow-up visits will continue after treatment for up to 20 weeks or longer if participants choose the extension phase.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

Researchers are evaluating the anti-cancer effects of inobrodib combined with pomalidomide and dexamethasone in adults with multiple myeloma that has returned after treatment and no longer responds to available therapies. This Phase II, open-label, multicenter study focuses on patients refractory to certain prior treatments, including proteasome inhibitors, anti-CD38 monoclonal antibodies, pomalidomide, and bispecific T-cell engagers. The study also examines the side effects of this combination treatment. Participants will receive 20 mg of inobrodib orally twice daily for 4 days on and 3 days off in each 28-day cycle. Pomalidomide is administered orally at 4 mg once daily from Day 1 to 21, and dexamethasone at 40 mg orally on Days 1, 8, 15, and 22 of each cycle. Treatment continues until disease progression, unacceptable toxicity, new anticancer therapy initiation, or study withdrawal. Approximately 100 patients will be treated following this schedule. During the study, participants will be regularly evaluated for treatment response using International Myeloma Working Group criteria by an Independent Review Committee. Researchers will monitor objective response rate, duration and time to response, progression-free survival, overall survival, and side effects including adverse events and laboratory changes. Safety assessments will continue for 28 days after treatment ends, with follow-up lasting up to 48 months from enrollment.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are evaluating a new multiomics assay called the Oricol Test, designed to detect colorectal cancer and significant polyps in patients showing symptoms and referred through the urgent suspected cancer pathway. The study aims to confirm known genetic, epigenetic, and microbiome biomarkers linked to colorectal cancer and high-risk adenomas, while also identifying additional rare biomarkers. The research also includes assessing the tests diagnostic performance, including sensitivity and specificity, and evaluating the health economics of delivering this diagnostic service through community centers compared to current pathways. The study involves collecting rectal mucus samples using the Oricol sampling device from patients referred for colonoscopy due to suspected colorectal cancer. This observational study focuses on analyzing these samples to develop and refine biomarker signatures associated with cancer and high-risk polyps. The research will measure various performance metrics of the assay over a 26-month period, alongside an economic assessment of the diagnostic approach. Participants will be adults aged 18 to 99 years who are referred via the urgent suspected cancer colorectal pathway and consent to participate. They will undergo rectal mucus sampling and possibly other clinical examinations like digital rectal exams. The study tracks biomarker presence and diagnostic accuracy while monitoring health economic outcomes. The total observation period for primary and secondary outcomes is 26 months, during which participants samples and data will be analyzed to evaluate the tests clinical utility and cost-effectiveness.