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Could a chicory root fiber supercharge immunotherapy against skin cancer?

NCT ID NCT07686835

Disease control Sponsor: Radboud University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This trial investigates whether adding dried chicory root fiber to standard immunotherapy helps people with advanced melanoma. The fiber is meant to increase beneficial gut bacteria, which may in turn improve immune cell activity and the body's response to treatment. About 70 participants will receive either the fiber supplement or a placebo alongside their immunotherapy, and researchers will track changes in gut bacteria and tumor shrinkage.

What this could mean

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

Active substance
dried chicory roots (dietary fiber)
What this could lead to
If it works, this could show that a simple dietary change helps the body's immune system fight melanoma more effectively.
What could go wrong
This is a small, early-phase trial testing a biomarker, not a direct cure. The fiber may not improve treatment response, and results may not apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 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 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: * Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease * Measurable disease according to RECIST 1.1 criteria * Age ≥ 18 years * Starting standard-of-care treatment with ICI in first line * Written informed consent must be given * Able to read and understand Dutch or English * Able to comply with study procedures (e.g. willing to provide fecal samples) Exclusion Criteria: * Symptomatic brain metastases * Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago * Use of systemic immunosuppressive medications * Use of laxatives up to 1 week prior to start of ICI * Use of supplements that alter bowel function or gut microbiota such as fibers/prebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI * Use of antibiotics up to 1 months prior to start of ICI * Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI * Pregnant or lactating * Current participation in another clinical trial requiring the use of study medication * Has a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower. * Has a medical history of gastrointestinal resection (appendectomy is allowed) * Has active inflammatory bowel disease

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma Melanoma (skin cancer) Melanoma (skin) stage IV Melanoma advanced Melanoma metastatic

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

  • Medical Oncology

    RECRUITING

    Nijmegen, Gelderland, 6525GA, Netherlands

  • Universitair Medisch Centrum Groningen

    NOT_YET_RECRUITING

    Groningen, Provincie Groningen, 9713GZ, Netherlands

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