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Can a simple blood test predict who responds to immunotherapy?

NCT ID NCT06075524

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study from Mayo Clinic is looking at how T cells (a type of immune cell) change during anti-PD-1 immunotherapy in people with advanced melanoma, lung cancer, or other solid tumors. Researchers will collect blood and tissue samples from 500 participants to measure specific markers like Bim and sPD-L1. The goal is to understand why some patients respond to treatment and others don't, and to find early signs of resistance.

What this could mean

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

What this could lead to
If successful, this could help doctors predict which patients will benefit from anti-PD-1 therapy and identify resistance early.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve outcomes for participants and may not lead to changes in clinical practice.

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.

Participants

About 500 people

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

Started

Jun 2015

Expected to finish

Dec 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.

Who is studied

Patients with metastatic melanoma, lung or other cancer recruited from the clinical practice in the Department of Oncology at Mayo Clinic in Rochester, Minnesota who are considered appropriate for starting therapy with an open-label commercially available, FDA approved anti-PD-1 monoclonal antibody by their treating provider.

Ages

18 years and older

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: * Are 18 years of age or older * Have histologic evidence of locally or regionally advanced or stage IV malignancy * Are considered appropriate for starting therapy with anti-PD-1/anti-PD-L1 monoclonal antibody by their treating physician (prior therapy with immune checkpoint inhibitor (ICI) is allowed) * Have an understanding of the protocol and its requirements, risks, and discomforts * Are willing to undergo peripheral blood collection at the time points mentioned in the protocol * Are able and willing to sign an informed consent Exclusion Criteria: * Inability on the part of the patient to understand the informed consent or be compliant with the protocol * Patients receiving any concurrent anti-cancer therapy or investigational agents (with the exception of an anti-PD-1/anti-PD-L1 agent as mentioned above) * Patients who are pregnant, nursing, or are of childbearing potential and are unwilling to employ adequate contraception

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Conditions

The condition(s) this trial relates to.

cancer cutaneous melanoma lung cancer lung carcinoma lung neoplasm melanoma metastatic carcinoma metastatic malignant neoplasm metastatic melanoma Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical stage III cutaneous melanoma ajcc V8 Clinical stage IV cutaneous melanoma ajcc V8 Locally advanced lung carcinoma Locally advanced malignant solid neoplasm Locally advanced melanoma Metastatic lung carcinoma Metastatic malignant solid neoplasm Metastatic melanoma Stage III lung cancer ajcc V8 Stage IV lung cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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