Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.

NCT07686835 | Recruiting Phase 2

• 1 other identifier: R0007807A
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Melanoma; Melanoma (Skin) Stage IV; Melanoma (Skin Cancer); Melanoma Metastatic; Melanoma Advanced

Keywords

microbiota; gut microbiota; dietary fiber; life-style

Outcome Measures

Primary Outcomes (1)

• An increase in the relative abundance of Bifidobacterium in fecal samples.

  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 Outcomes (5)

• Fecal microbiota composition

  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

  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)

  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)

  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

  From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI.

Other Outcomes (8)

• Habitual dietary intake (Food Frequency Questionnaire)

  At baseline (T0) and at 3-4 months (T2)

• Physical activity level (Short QUestionnaire to ASsess Health-enhancing physical activity)

  At baseline (T0) and at 3-4 months (T2)

• Sleep quality and duration (Pittsburgh Sleep Quality Index)

  At baseline (T0) and at 3-4 months (T2)

Study Arms (2)

Fiber intervention arm

EXPERIMENTAL

Dried chicory roots

Dietary Supplement: Dried chicory roots

Placebo arm

PLACEBO COMPARATOR

iso-caloric placebo (rice-puffs)

Dietary Supplement: Placebo

Interventions

Dried chicory roots DIETARY_SUPPLEMENT

The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day.

Also known as: Dietary fibers, fiber, Vezel

Fiber intervention arm

Placebo DIETARY_SUPPLEMENT

The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.

Also known as: Placebo control, Control

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Wageningen University and Research: collaborator

Study Sites (2)

Medical Oncology

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Kalijn Bol, dr.

CONTACT

+31 243618800; Kalijn.Bol@radboudumc.nl

Isabel Ossekoppele, MS

CONTACT

Isabel.Ossekoppele@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The FIGURE-IM is a randomized, double-blind, placebo-controlled, phase II clinical trial with two-arms to assess the effect of dietary fiber supplementation on the gut microbiota in patients with metastatic melanoma. Participants will be stratified based on gender and standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). In the experimental arm the participants will receive fiber rich dried chicory roots additional to the habitual diet while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). The participants from the placebo/control arm receive rice puffs which contain a neglectable amount of fiber while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). Participants will be randomized 1:1.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 7, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

NL (2)