Study of Early PETCT Scans and Blood Tests to Predict Response and Side Effects in Advanced Melanoma Patients Receiving Immune Checkpoint Inhibitor Therapy

What this Trial Is About

Researchers are investigating whether early analysis of PETCT scans and blood tests can help predict how people with advanced melanoma respond to immune checkpoint inhibitor ICI therapy. This observational study focuses on patients with stage III or IV melanoma and aims to understand the relationship between imaging results, circulating tumor DNA ctDNA levels, treatment response, side effects, and survival outcomes. The study is led by the University of Wisconsin, Madison, and enrolls 24 participants. Participants will undergo baseline and early interval 18F-FDG PETCT scans approximately 3 to 4 weeks after starting ICI therapy, such as ipilimumab, nivolumab, or pembrolizumab. Blood samples will be tested for ctDNA levels at the same intervals to observe changes during treatment. This study does not involve administering treatments but observes participants receiving standard ICI care. The early imaging and ctDNA tests aim to correlate with treatment response and side effect development. During the study, participants will be followed until about 4 weeks after their first ICI dose for initial measurements and may be monitored up to 3 years for progression-free and overall survival outcomes. Researchers will collect data from scans, blood tests, clinical assessments, and standard laboratory monitoring. The study evaluates changes in ctDNA and PETCT findings to predict treatment effectiveness and immune-related side effects, with safety and survival tracked throughout the follow-up period.

Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients