Using a Blood Test to Guide How Long Immunotherapy Lasts in Advanced Melanoma
Tests a blood test to guide immunotherapy length in people with advanced melanoma.
Plain-language title generated from the registry record
Registry title: A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.
Key facts
- Where
- New Brunswick, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT07830225, who can take part
Where in United States
- Rutgers Cancer InstituteNew Brunswick, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rutgers, The State University of New Jersey
- Trial code
- NCT07830225
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.
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.
Inclusion: 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 treatment discontinuation. Patients must have a radiographic RECIST PR or CR at the treatment duration decision time point; 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; ECOG performance status 0-2.
Exclusion: Participants who are receiving investigational therapies; Patients who have had their melanoma completely surgically resected such that response to immunotherapy is no longer evaluable; Patients who are unwilling to continue or stop ICI therapy using ctDNA guidance in combination with imaging response; Patients with best response of progressive disease at time of screening; History of a life-threatening or severe irAE that would make ICI rechallenge unsafe. These cases will be discussed with the Principal Investigator; Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study; Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing; Intracranial-only metastatic melanoma.