MelanomaFIBIOMENCT07437300
Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.
An observational study of Melanoma, run by University Hospital, Grenoble.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- 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)
Who cannot join
- 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.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Melanoma
- Keywords
- immunotherapy, high-fiber diet
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Occurrence of immunotoxicity with its CTCAE v5.0
Measured: 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
Muscle surface index on L3 CT scan using ODIASP software and objective response rate to immunotherapy
Measured: 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
Presence of malnutrition at the start of treatment and objective response rate to immunotherapy
Measured: 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
High physical activity (GPAQ score) and objective response rate to immunotherapy
Measured: follow-up imaging at 3 and 6 months in curative and adjuvant settings
association between uncontrolled diabetes (HbA1c > 7%) and response to immunotherapy
Uncontrolled diabetes (HbA1c > 7%) and objective response rate to immunotherapy
Measured: follow-up imaging at 3 and 6 months in curative and adjuvant settings
association between antibiotic use in the 3 months prior to the start of treatment and response to immunotherapy
Antibiotic use within 3 months prior to the start of treatment and objective response rate to immunotherapy
Measured: follow-up imaging at 3 and 6 months in curative and adjuvant settings
association between prebiotic or probiotic use and response to immunotherapy
Pre- or probiotic intake and objective response rate to immunotherapy
Measured: follow-up imaging at 3 and 6 months in curative and adjuvant settings
ssociation between alcohol consumption and response to immunotherapy
Alcohol consumption and objective response rate to immunotherapy
Measured: follow-up imaging at 3 and 6 months in curative and adjuvant settings
association between tobacco consumption and response to immunotherapy
Tobacco consumption and objective response rate to immunotherapy
Measured: follow-up imaging at 3 and 6 months in curative and adjuvant settings
Association between the presence of a pet in the patient's home and response to immunotherapy
Presence of a pet in the patient's home and objective response rate to immunotherapy
Measured: follow-up imaging at 3 and 6 months in curative and adjuvant settings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Charles, MD, PhD, Principal investigator, University Grenoble Alpes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437300
- Sponsor's protocol ID
- 38RC25.0434
- Other IDs
- ID-RCB number
- Acronym
- FIBIOME
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.
- ClinicalTrials.gov ID
- NCT07437300
- Acronym / sponsor ID
- FIBIOME / 38RC25.0434
- Conditions
- Melanoma
- Keywords
- immunotherapy, high-fiber diet
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
association between a high-fiber diet and the occurrence of immunotoxicity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings
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
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
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
ssociation between alcohol consumption and response to immunotherapy
Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings
association between tobacco consumption and response to immunotherapy
Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Charles, MD, PhD principal investigator
University Grenoble Alpes Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Charles, MD, PhD (0476769320 ext. +33, jcharles@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.