Dietary fiber to induce gut microbiota-mediated response to immunotherapy in melanoma (FIGURE-IM)
The objective is to study the effect of dried chicory root on the gut microbiota composition and its immunological effects in participants with melanoma treated with ICI. We will perform the FIGURE-IM trial, a double-blind, randomized, placebo-controlled two arm clinical phase II trial in participants with metastatic melanoma starting first-line ICI as standard-of-care. Patients will be randomized between supplementation of the habitual diet with dried chicory root fibers or with a placebo.
Belangrijkste inclusiecriteria
∙ 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
Belangrijkste exclusiecriteria
∙ Symptomatic brain metastases
∙ Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago
∙ Use of systemic immunosuppressive medications
∙ Use of laxatives up to 1 week prior to start of ICI
∙ Use of supplements that alter bowel function or gut microbiota such as fibers/prebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI
∙ Use of antibiotics up to 1 months prior to start of ICI
∙ Use of proton pumps inhibitors (PPI’s) up to 3 months prior to start of ICI
∙ Has active inflammatory bowel disease
Kalijn Bol, RadboudUMC