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.
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.
Any line of therapy, with the exception of adjuvant therapy.
Ability to understand and the willingness to sign a written informed consent document.
Patients with brain metastasis may be included only if there was also presence of extracranial disease.
Participants who are receiving investigational therapies.
Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing.
Intracranial-only metastatic melanoma.
Patients with best response of progressive disease at time of screening.
Single group
A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma
Other interventionThis 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.
Primary Outcome
To determine whether ctDNA can safely and feasibly guide ICI treatment duration decisions in patients with advanced melanoma by measuring the proportion of patients who demonstrate persistently undetectable ctDNA in the 12 months following treatment discontinuation
Secondary Outcome 1
To evaluate progression-free survival (PFS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA
Secondary Outcome 2
To evaluate overall survival (OS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA
Outcome measure 3
To evaluate treatment-free survival (TFS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA
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