Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma. (FIGURE-IM)

July 24, 2026 updated by: Radboud University Medical Center
Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Recruiting
        • Medical oncology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kalijn Bol, dr.
        • Sub-Investigator:
          • Carla van Herpen, Prof.
        • Sub-Investigator:
          • Isabel Ossekoppele, MS.
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9713GZ
        • Not yet recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
        • Principal Investigator:
          • Kalijn Bol, dr.
        • Sub-Investigator:
          • Isabel Ossekoppele, MS.
        • Contact:
        • Principal Investigator:
          • Sjoukje Lubberts, dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fiber intervention arm
Dried chicory roots
Dietary supplement: Dried chicory roots
The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day.
Other Names:
  • Dietary fibers
  • fiber
  • Vezel
Placebo Comparator: Placebo arm
iso-caloric placebo (rice-puffs)
Dietary supplement: Placebo
The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.
Other Names:
  • Control
  • Placebo control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
An increase in the relative abundance of Bifidobacterium in fecal samples.
Time Frame: From baseline (T0) to 3-4 weeks (T1) after start ICI
The primary endpoint of this study is defined as a ≥5% (e.g. from 3% to 8%) increase in the relative abundance of Bifidobacterium in fecal samples between baseline (T0) and follow-up (T1) and significant differences between the experimental arm and the control arm.
From baseline (T0) to 3-4 weeks (T1) after start ICI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fecal microbiota composition
Time Frame: Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Study the baseline and on-treatment gut microbiota composition of patients with melanoma treated with ICI +/- additional dietary fiber.
Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Radiological response rate to ICI
Time Frame: From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Evaluate radiological response rates to ICI +/- additional dietary fiber, assessed by CT/PET scan per RECIST 1.1 defined as; the date of randomization to the date of disease progression or death, respectively.
From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Progression free survival (PFS)
Time Frame: From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Evaluate progression-free survival defined as; the date of randomization to the date of disease progression or death, respectively.
From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Overall survival (OS)
Time Frame: From baseline (T0) on, survival follow-up will be continued after study completion for a maximal of 5 years in accordance with standard-of-care follow-up.
Evaluate overall survival to ICI +/- additional dietary fiber defined as; the date from randomization to date of death, respectively.
From baseline (T0) on, survival follow-up will be continued after study completion for a maximal of 5 years in accordance with standard-of-care follow-up.
Evaluate the gastro-intestinal side effects of additional dietary fiber intake
Time Frame: From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI.
Evaluate the gastro-intestinal side effects of additional dietary fiber intake, according to CTCAE common criteria v 5.0.
From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Habitual dietary intake (Food Frequency Questionnaire)
Time Frame: At baseline (T0) and at 3-4 months (T2)
Nutritional intake is measured using a semi-quantitative Food Frequency Questionnaire (FFQ). Scores are calculated using the Dutch National Food Consumption tables. The FFQ will be used to evaluate habitual diet and fiber intake.
At baseline (T0) and at 3-4 months (T2)
Physical activity level (Short QUestionnaire to ASsess Health-enhancing physical activity)
Time Frame: At baseline (T0) and at 3-4 months (T2)
Physical activity is measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). The questions in the SQUASH are pre-structured in commuting, leisure time, household and work/school activities. Scores will be assigned to the different reported activities base on intensities in MET and translated to minutes of physical activity.
At baseline (T0) and at 3-4 months (T2)
Sleep quality and duration (Pittsburgh Sleep Quality Index)
Time Frame: At baseline (T0) and at 3-4 months (T2)
Sleep quality is measured with the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with scores ranging from 0-21. A score above 5 indicates bad sleep quality.
At baseline (T0) and at 3-4 months (T2)
Bristol Stool Scale (BSS)
Time Frame: Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Stool consistency is measured using the Bristol Stool Scale (BSS)
Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Circulating tumor DNA (ctDNA)
Time Frame: Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
ctDNA levels will be analysed to evaluate circulating tumor DNA.
Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Short-Chain Fatty Acids
Time Frame: Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Fecal and Plasma SCFA's levels will be evaluated.
Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Sequencing mRNA in circulating immune cells
Time Frame: Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
(m)RNA will be sequenced to evaluate the transcription/gene expression in circulating immune cells.
Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Tumor infiltration
Time Frame: Pretreatment

Archived tumor tissue, previous to baseline (T0):

Pre-interventional tumor tissue will be requested for immune cell analyses using multiplex immunohistochemistry.
Pretreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wageningen University and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R0007807A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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