A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.

This is a study of patients with advanced melanoma who are potentially eligible to stop or shorten their duration of ICI. Patients with radiographic disease control and/or response with undetectable ctDNA levels will stop ICI therapy after 1 year. Patients who have responded to ICI but have experienced immune-related adverse events (irAE) requiring treatment interruption and immunosuppression are also eligible and will stop ICI therapy if ctDNA is undetectable. All patients with undetectable ctDNA who candidates are to stop treatment will undergo monitoring with standard of care imaging and ctDNA assessments every three months to assess for the primary outcome of the 12-month sustained ctDNA negativity rate. Undetectable ctDNA for the purposes of the treatment duration decision time point is defined as two consecutive negative ctDNA tests performed at least 4 weeks apart. If ctDNA is detectable at the treatment duration decision time point, treatment will be continued as per an investigator's choice regimen. In patients whose ctDNA converts from undetectable to detectable during the monitoring period, the investigator may choose to restart ICI based upon imaging findings and/or other relevant clinical factors.