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Blood test could tell melanoma patients when to stop immunotherapy

NCT ID NCT07830225

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 90 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Rutgers Cancer Institute

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

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