NCT07437300
Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.
Not Yet Recruiting · Not specified · University Hospital, Grenoble · registry updated 2026-02-27
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
Inclusion
- 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
- 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