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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying patients with metastatic melanoma to compare two ways of giving PD-1 inhibitor therapy, a type of immunotherapy that helps the immune system fight cancer. The study aims to find out if taking PD-1 inhibitors intermittently with breaks works as well as continuous non-stop treatment in extending patients lives. This is a Phase III randomized trial led by the Canadian Cancer Trials Group. Participants receive PD-1 inhibitors that are government approved and publicly funded, with doses recommended by the manufacturer. One group takes the treatment continuously for up to two years, while the other takes it intermittently, with breaks when the melanoma improves. The trial compares these two treatment schedules to see if intermittent therapy can provide similar benefits with potentially fewer clinic visits, side effects, and costs. During the study, participants will be monitored over seven years to assess overall survival as the main outcome. Researchers will also measure progression-free survival, response rates, duration of response, side effects, quality of life, and economic impact using questionnaires and clinical evaluations. Participants must complete quality of life questionnaires in English or French and be available for treatment and follow-up visits throughout the study period.
Actively Recruiting
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.