Dundowran

Researchers are studying an experimental drug called fianlimab combined with cemiplimab, comparing it to cemiplimab combined with a placebo, in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been previously treated. The study also explores side effects, drug levels in the blood, and whether the body produces antibodies against the study drugs, which could affect their action or cause side effects. Participants are divided into two groups based on HPV status and randomized to receive either the fixed-dose combination of fianlimab and cemiplimab or cemiplimab plus placebo. Approximately 60 participants each with HPV-positive and HPV-negative HNSCC will be enrolled. The drugs are administered according to the study protocol, and participants receive treatment as part of this randomized, phase II trial. During the study, participants will be monitored for treatment response, side effects, and drug levels in their blood. Researchers will assess overall response rates and various adverse events up to 90 days after the last treatment and for approximately 58 months total. Safety, disease control, progression, and immune responses will be closely evaluated throughout the study period.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

Researchers are conducting a prospective observational study to understand the natural progression of coronary plaque buildup in people with melanoma who are treated with immune checkpoint inhibitors ICIs. The study focuses on assessing coronary atherosclerosis and cardiovascular risk factors in this population. It is sponsored by Monash University and takes place across several sites in Australia. Participants are observed without any experimental treatments being administered by the study. The study evaluates how statin use relates to the amount and progression of coronary artery disease in patients treated with ICIs. The study also looks at the effects of using CT coronary angiography CTCA to guide preventive statin therapy. Various outcomes are assessed over an 18-month period. During the study, participants undergo imaging tests such as CTCA and assessments of their cardiovascular risk factors and quality of life. Researchers will track major cardiovascular events, melanoma progression-free survival, and overall survival. The study requires follow-up visits and imaging, and participants are monitored for up to 18 months to gather these data.