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Clinical Trials in the Netherlands / NCT07686835
Recruiting Phase 2

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

NCT07686835 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Radboud University Medical Center
Phase
Phase 2
Started
2026-07-31
Last updated
2026-07-27

Condition(s) studied

Melanoma (Skin) Stage IVMelanoma (Skin Cancer)Melanoma MetastaticMelanoma AdvancedMelanoma

Investigational drug(s) / intervention(s)

Dried chicory rootsPlacebo

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (2)

FacilityCityRegionStatus
Medical Oncology Nijmegen Gelderland Recruiting
Universitair Medisch Centrum Groningen Groningen Provincie Groningen Not Yet Recruiting

More Radboud University Medical Center trials in the Netherlands

Timing of Immunotherapy in Melanoma Recruiting
Preventive Dendritic Cell Vaccination for Lynch Syndrome Carriers Starting soon
The Effects of Mindfulness-based Cognitive Therapy in People With Parkinson's Disease Active, not recruiting
Enhancement of Quality of Work And Life Active, not recruiting
Pain Predict Genetics Active, not recruiting

Other trials for the same condition

Timing of Immunotherapy in Melanoma Recruiting
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting
NO Re-excision MelanomA - NORMA 2 Recruiting
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Active, not recruiting
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07686835 on ClinicalTrials.gov ↗ ← All trials in the Netherlands