Mildura

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are comparing two ways of giving PD-1 inhibitor treatment to patients with metastatic melanoma: continuously without breaks, or intermittently with planned breaks. PD-1 inhibitors are a type of immunotherapy that help the immune system fight melanoma. The study aims to find out if intermittent treatment is as effective as continuous treatment in extending patients' lives. This is a Phase 3 trial focused on overall survival over seven years. Participants will receive either intermittent PD-1 inhibitor therapy, where treatment pauses are taken when the melanoma improves, or continuous PD-1 inhibitor therapy without breaks. The study treatments involve government-approved and publicly funded PD-1 inhibitors. The intermittent approach may reduce clinic visits, side effects, and costs if found to be as effective as continuous therapy. During the study, participants will be followed closely with assessments to monitor their disease status and quality of life. They must complete questionnaires in English or French to evaluate health outcomes. Researchers will track overall survival for up to seven years and monitor treatment effects and safety. Patients must be available for treatment and follow-up to ensure complete data collection throughout the study.

Researchers are studying how coronary artery plaque develops and changes over time in people with melanoma who have been treated with immune checkpoint inhibitors (ICIs). This prospective observational study aims to understand the natural progression of coronary atherosclerosis in this group. The study is being conducted at various sites across Australia and focuses on adults aged 40 years and older with melanoma at any stage who have received or are planned to receive ICI treatment. Participants will be monitored primarily for 18 months to assess the burden and composition of coronary plaque. The study involves imaging assessments, specifically coronary computed tomography angiography (CTCA), to evaluate the state of coronary arteries. No investigational treatments are administered as this is an observational study focusing on natural disease progression. During the study, participants will undergo follow-up CTCA scans and other assessments to monitor coronary artery health. Researchers will collect data on coronary plaque characteristics and progression while monitoring the participants' adherence to the protocol over the study duration. Safety and eligibility will be continuously assessed, and participants may be followed for up to 18 months to understand long-term outcomes related to coronary atherosclerosis in melanoma patients treated with ICIs.