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

24 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Nederland
    • Gelderland
      • Nijmegen, Gelderland, Nederland, 6525GA
    • Provincie Groningen
      • Groningen, Provincie Groningen, Nederland, 9713GZ
        • Nog niet aan het werven
        • Universitair Medisch Centrum Groningen
        • Contact:
        • Hoofdonderzoeker:
          • Kalijn Bol, dr.
        • Onderonderzoeker:
          • Isabel Ossekoppele, MS.
        • Contact:
        • Hoofdonderzoeker:
          • Sjoukje Lubberts, dr.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Fiber intervention arm
Dried chicory roots
Voedingssupplement: 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.
Andere namen:
  • Dietary fibers
  • fiber
  • Vezel
Placebo-vergelijker: Placebo arm
iso-caloric placebo (rice-puffs)
Voedingssupplement: Placebo
The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.
Andere namen:
  • Controle
  • Placebo-controle

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
An increase in the relative abundance of Bifidobacterium in fecal samples.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fecal microbiota composition
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Habitual dietary intake (Food Frequency Questionnaire)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Pretreatment

Archived tumor tissue, previous to baseline (T0):

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Radboud University Medical Center

Medewerkers

Wageningen University and Research

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 juli 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

30 april 2029

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2026

Eerst geplaatst (Werkelijk)

7 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R0007807A

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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