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Blood test may help cancer patients stop treatment early

NCT ID NCT06146920

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This study is testing whether a blood test that looks for tumor DNA can help doctors decide when to safely stop immunotherapy in people with advanced melanoma or non-small cell lung cancer. About 39 patients who have been on immunotherapy for at least a year and show no signs of tumor DNA in their blood will stop treatment and be monitored. The goal is to see if these patients stay cancer-free for at least 12 months without needing more therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
circulating tumor DNA (ctDNA) blood test
What this could lead to
If successful, this could provide a way to know when it's safe to stop immunotherapy, reducing unnecessary treatment and side effects for some patients.
What could go wrong
This is a small pilot study with only 39 people, so results may not apply to everyone. The blood test might miss some tumors or give false reassurance.

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 39 people

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

Started

Jan 2024

Expected to finish

Nov 2028

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adult patients age \> 18) with unresectable, metastatic melanoma (cutaneous, acral, mucosal) or NSCLC who have evidence of disease control after at least 12 months of ICI based therapy (pembrolizumab, nivolumab, nivolumab-relatimab, ipilimumab/nivolumab, atezolizumab, ipilimumab, durvalumab, cemiplimab) with or without chemotherapy in the case of NSCLC. Any line of therapy is permitted with the exception of adjuvant therapy * Participants must be actively receiving standard of care ICI-based therapy (ICI monotherapy or in combination) * At time of enrollment patients must have received at least 12months (+/- 4 weeks) from the start of anti-PD-1 therapy and have not experienced a toxicity that prevented them from continuing therapy. * Participants must have evidence of disease control (stable disease, partial response, or complete response) that is maintained on restaging CT scans or PET CT scans obtained at 12 months (+/- 4 weeks) from the start of initial ICI therapy * Prior radiation to any site is allowed * Available tumor tissue (archival) for baseline tissue testing with FoundationOne CDx or previous FoundationOne CDx testing results (within 2 years and prior test results must be after June 30, 2021) * Life expectancy of greater than 3 months * Participants with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment are eligible for this trial. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants with clinical or radiographic evidence of progressive disease in the 3 months prior to consideration of screening and enrollment * Participants who are receiving an investigational agent (s) * Participants who have had ICI discontinued due an immune-related adverse event. * Patients with a history of an irAE but resumed ICI therapy and are receiving ICI at the time of screening are eligible to enroll. * Participants on \> 10mg of oral prednisone or its equivalent for treatment of ongoing immune-related toxicity. * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia, endocrine toxicity requiring chronic supplementation * Participants with a concurrent, active malignancy * Participants in whom F1CDx generation fails * Participants without available tumor tissue for F1CDx test result or prior F1CDx

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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.

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.