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

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.

Trial Details

NCT ID
NCT07686835
Phase
PHASE2
Sponsor
Radboud University Medical Center
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Dried chicory roots
  • Placebo
Locations (sample)
  • Nijmegen, Gelderland, Netherlands|51.8425,5.85278
  • Groningen, Provincie Groningen, Netherlands|53.21917,6.56667

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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