Rutgers, The State University of New Jersey
This is a phase II pilot study evaluating the use of circulating tumor DNA (ctDNA) to guide the optimal duration of standard of care immune checkpoint inhibitor (ICI) therapy in patients with unresectable and/or metastatic melanoma who have radiographic evidence of disease control and/or response to treatment.
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 ct…
Inclusion Criteria: 1. Age \> 18 with any subtype of unresectable stage III or stage IV melanoma treated with anti-PD-1-based ICI which includes both anti-PD-1 monotherapy and dual checkpoint inhibitor regimens such as ipilimumab plus nivolumab and nivolumab plus relatlimab. Disease control after at least 6-12 months of anti-PD-1-based ICI defined as a radiographic RECIST CR, PR, or SD and planned for at least 1 year of treatment OR Development of an irAE(s) on an anti-PD-1-based regimen requiring treatment interruption and immunosuppression where the investigator is considering t…
This is a phase II pilot study evaluating the use of circulating tumor DNA (ctDNA) to guide the optimal duration of standard of care immune checkpoint inhibitor (ICI) therapy in patients with unresectable and/or metastatic melanoma who have radiographic evidence of disease control and/or response to treatment.
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