NCT07437300

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Feb 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

February 20, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Melanoma

Keywords

immunotherapyhigh-fiber diet

Outcome Measures

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

    Objective response rate to immunotherapy according to RECIST 1.1 criteria

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

Secondary Outcomes (10)

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

    during 6 months of immunotherapy initiation

  • 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

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

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

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

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

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

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

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

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated by immunotherapy for melanoma in curative or adjuvant settings for less than one year in the dermatology day hospital at Grenoble Alpes University Hospital

You may qualify if:

  • 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
  • Subject affiliated with social security system

You may not qualify if:

  • 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.)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Julie Charles, MD, PhD

    University Grenoble Alpes Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Charles, MD, PhD

CONTACT

0476769320jcharles@chu-grenoble.fr

Stéphane Mouret, PhD

CONTACT

0476767081smouret1@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02