Blood test could tell melanoma patients when to stop immunotherapy
NCT ID NCT07830225
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether a blood test for circulating tumor DNA (ctDNA) can help decide when patients with advanced melanoma can safely stop immune checkpoint inhibitor therapy. The study enrolls adults whose tumors have responded to or stabilized on these drugs for at least 6 to 12 months. Participants with undetectable ctDNA may discontinue treatment, and researchers track whether the cancer stays away over the following year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ctDNA-guided immune checkpoint inhibitor treatment duration
- What this could lead to
- If it works, this approach could let some advanced melanoma patients stop immunotherapy earlier without their cancer returning, sparing them ongoing side effects and costs.
- What could go wrong
- This is a small pilot study of 35 people, so it may not show whether undetectable ctDNA reliably predicts safe discontinuation. Stopping immunotherapy too soon could allow the cancer to progress.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 treatment discontinuation. Patients must have a radiographic RECIST PR or CR at the treatment duration decision time point. 2. Any line of therapy, with the exception of adjuvant therapy. 3. Ability to understand and the willingness to sign a written informed consent document. 4. Patients with brain metastasis may be included only if there was also presence of extracranial disease. 5. ECOG performance status 0-2. Exclusion Criteria: 1. Participants who are receiving investigational therapies. 2. Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing. 3. Intracranial-only metastatic melanoma. 4. Patients with best response of progressive disease at time of screening. 5. Patients who have had their melanoma completely surgically resected such that response to immunotherapy is no longer evaluable. 6. Patients who are unwilling to continue or stop ICI therapy using ctDNA guidance in combination with imaging response. 7. History of a life-threatening or severe irAE that would make ICI rechallenge unsafe. These cases will be discussed with the Principal Investigator. 8. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rutgers Cancer Institute
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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