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Gut check: could your microbiome predict immunotherapy success?

NCT ID NCT06050733

Knowledge-focused Sponsor: The University of Texas Medical Branch, Galveston 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the gut bacteria of 16 people with advanced solid cancers who are receiving standard immunotherapy. Researchers will analyze stool samples and cognitive function to see if there is a link between the gut microbiome and how well the treatment works. The goal is to gather knowledge, not to test a new drug.

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 understand why some patients respond better to immunotherapy based on their gut bacteria.
What could go wrong
This is a very small, early observational study with only 16 people. It is not testing a treatment, so it may not lead to any direct changes in care.

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 16 people

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

Started

Jun 2023

Expected to finish

Dec 2026

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 from cancer clinic

Ages

35 to 75 years

Sex

Anyone

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. Current diagnosis of malignant solid cancer that is nonresectable or metastatic. 2. Ages 35 to 75 years. 3. Treatment with immunotherapy, specifically programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) inhibitor, for at least 3 months but less than 24 months (except for previously responsive subjects re-enrolling as non-responsive patients). 4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. 5. Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: 1. Significant heart, liver, blood or respiratory disease. 2. Current diagnosis of HIV, Hepatitis B or Hepatitis C. 3. History of heart disease. 4. Uncontrolled diabetes mellitus. 5. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease. 6. Females who are pregnant or lactating. 7. Treatment with chemotherapy within the past 2 years. 8. Treatment with kinase inhibitors within the past 3 months. 9. Previous radiation therapy for brain metastases. 10. Other medical condition or medication administration deemed exclusionary by the study investigators.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

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

Cancer

How to take part

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

  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.

    Open the record ↗

  3. 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

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 77845, United States

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