Gut Microbiome Composition and Response to Immune Checkpoint Inhibitors in Melanoma: A Systematic Review
Abstract
Immune checkpoint inhibitors have significantly improved clinical outcomes in patients with advanced melanoma; however, treatment response remains highly variable, and reliable predictive biomarkers are lacking. Emerging evidence suggests that the gut microbiome influences host immune regulation and may contribute to this variability. This systematic review evaluated the association between gut microbiome composition and response to immune checkpoint inhibitors in melanoma, with a focus on potential biological mechanisms, predictive biomarkers, and therapeutic implications. A systematic search of the PubMed database was conducted to identify studies published between 2015 and 2025. Eligible studies included original observational investigations and secondary analyses of melanoma microbiome datasets that examined associations between gut microbiome characteristics and response to immune checkpoint inhibitors. Interventional fecal microbiota transplantation studies, dietary or probiotic intervention trials, exposure-only studies (including antibiotic, proton pump inhibitor, or Helicobacter pylori exposure without direct microbiome sequencing), non-English-language publications, and preprints were excluded. The search identified 381 records. After removal of one duplicate, 380 records were screened, and 25 studies met the inclusion criteria. Across the included studies, gut microbiome composition, microbial diversity, and metabolic function were associated with immunotherapy…
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