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NCT Number: NCT07437300

Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.

The underlying hypothesis of the study is that melanoma patients treated with immunotherapy, whether in an adjuvant or curative setting, who consume more fiber would respond better to immunotherapy: either no recurrence in the case of adjuvant treatments, or no progression (disease stability, partial or complete response) in the case of curative treatments.

The primary objective is to evaluate the association between total dietary fiber intake quantified using the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Melanoma treated with curative immunotherapy (IPILIMUMAB + NIVOLUMAB or NIVOLUMAB or PEMBROLIZUMAB or NIVOLUMAB + RELATLIMAB) or adjuvant immunotherapy (NIVOLUMAB or PEMBROLIZUMAB)
  • Patients monitored and treated at the dermatology day hospital at Grenoble Alpes University Hospital
  • Obtaining the patient's consent
  • Start of immunotherapy less than or equal to 1 year at the time of inclusion
  • Subject affiliated with social security system

Exclusion criteria

  • Recurrence of the disease within 6 months or less after a first line of adjuvant treatment with immunotherapy for 1 year
  • Immunotherapy as a third line of treatment in metastatic situations
  • Squamous cell carcinoma or basal cell carcinoma treated with immunotherapy
  • Inability to complete the FiberTAG and GPAQ questionnaires (advanced neurocognitive disorders, memory loss, etc.)
  • Inclusion in an interventional clinical study
  • Immunotherapy in a neoadjuvant situation
  • Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care institution for purposes other than research, minors, persons subject to legal protection measures or unable to give their consent). persons subject to legal protection measures)

Treatment and study plan

Primary outcomes

  1. Association between total dietary fiber intake based on the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Objective response rate to immunotherapy according to RECIST 1.1 criteria

Secondary outcomes

  1. association between a high-fiber diet and the occurrence of immunotoxicity

    Time frame: during 6 months of immunotherapy initiation

    Occurrence of immunotoxicity with its CTCAE v5.0

  2. association between muscle surface index on L3 CT scan using ODIASP software (Automated Computerized Muscle Surface Determination Tool at the Psoas Level) and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Muscle surface index on L3 CT scan using ODIASP software and objective response rate to immunotherapy

  3. association between the presence of malnutrition at the start of treatment and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Presence of malnutrition at the start of treatment and objective response rate to immunotherapy

  4. association between high physical activity (GPAQ (Global Physical Activity Questionnaire) score) and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    High physical activity (GPAQ score) and objective response rate to immunotherapy

  5. association between uncontrolled diabetes (HbA1c > 7%) and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Uncontrolled diabetes (HbA1c > 7%) and objective response rate to immunotherapy

  6. association between antibiotic use in the 3 months prior to the start of treatment and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Antibiotic use within 3 months prior to the start of treatment and objective response rate to immunotherapy

  7. association between prebiotic or probiotic use and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Pre- or probiotic intake and objective response rate to immunotherapy

  8. ssociation between alcohol consumption and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Alcohol consumption and objective response rate to immunotherapy

  9. association between tobacco consumption and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Tobacco consumption and objective response rate to immunotherapy

  10. Association between the presence of a pet in the patient's home and response to immunotherapy

    Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

    Presence of a pet in the patient's home and objective response rate to immunotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Charles, MD, PhD

CONTACT

[email protected]

0476769320 ext. +33

Stéphane Mouret, PhD

CONTACT

[email protected]

0476767081 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: FIBIOME

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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