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Could a probiotic help fight cancer? early trial launches

NCT ID NCT06398418

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 5 times

Summary

This early-stage trial is testing whether an oral probiotic called R-5780 is safe and tolerable when taken alongside a standard PD-1 checkpoint inhibitor in people with advanced solid tumors (like melanoma or certain skin cancers). About 33 adults whose cancer has not responded to prior immunotherapy will take the probiotic and be monitored for side effects and quality of life. The goal is to see if this combination can be given safely, not yet to prove it works.

What this could mean

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

Active substance
R-5780 (a probiotic taken by mouth)
What this could lead to
If it works, this could point toward a way to boost the immune system's ability to fight tumors using a simple probiotic.
What could go wrong
This is a very early (Phase 1) and small (33 people) study focused on safety, not effectiveness. The probiotic may not improve cancer control and could cause unexpected side effects.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 33 people

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

Started

Aug 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 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: * At least 18 years of age to 80 * Ability to provide written informed consent * Unresectable stage III or stage IV melanoma, basal cell carcinoma, or squamous cell carcinoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status and other solid tumors. * Refractory to anti-PD (checkpoint Protein on Immune Cells called T cells)-1/L1 therapy per RECIST v1.1 defined as subject who has disease progression after receiving at least two complete cycles of ICI (immune checkpoint inhibitors) therapy or disease progression 6 months from initiation of ICI (immune checkpoint inhibitors) therapy while still on active therapy. * Life expectancy of greater than 3 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Subjects must have evaluable disease by CT (computer tomography) or MRI (magnet resonance imaging) per RECIST 1.1 criteria or clinically apparent disease that the investigator can follow for response. Exclusion Criteria: * Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the Investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess * Treatment with systemic broad-spectrum antibiotics. * No active viral infections. * Coexisting severe chronic diseases other than cancer (autoimmunity, inflammatory diseases) * Secondary gastrointestinal motility disorders * History of solid organ transplant or bone marrow transplant * Prior CAR-T (chimeric antigen receptor) or allogeneic cellular therapy * Ongoing systemic immunosuppressive therapy, with the exclusion of prednisone (10 mg/day) * Concurrent therapy with any other investigational agent, vaccine, or device * Pregnant or breastfeeding or planning to conceive or father a child during the trial period * Subjects with untreated brain metastasis. Treated brain metastasis are permitted if stable * More than 4 prior systemic therapies * Other cancer medications during treatment period are not permitted * Enrollment in other clinical trials.

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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.

  1. The places running it

    2 sites. 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

  • Sarah Cannon Research Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

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