{"entity":{"id":"mimic-01","kind":"trial","name":"MIMic-01: healthy-donor FMT plus anti-PD-1, first-line melanoma","aka":[],"tldr":"Twenty melanoma patients took stool capsules from healthy donors before starting immunotherapy. Thirteen responded, more than usually expected, and the transplant was safe.","summary":"Phase 1 safety trial of healthy-donor capsule FMT (about 80-100 capsules, single dose) combined with first-line anti-PD-1. Objective response rate was 65% (13 of 20), including 4 complete responses, versus a historical 40-45% for anti-PD-1 monotherapy; responders had greater engraftment of donor strains and increased abundance of immunogenic taxa. Grade 3 immune-related adverse events occurred in 5 patients, none attributed to FMT. The trial moved FMT from a salvage strategy to a potential first-line adjunct and led to the Canadian Cancer Trials Group randomised phase 2 (LND101, NCT06623461). The historical comparison is not a control and the sample is small.","status":"active","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT03772899","url":"https://clinicaltrials.gov/study/NCT03772899"},{"label":"Routy et al. (Nat Med 2023)","url":"https://doi.org/10.1038/s41591-023-02453-x"},{"label":"ClinicalTrials.gov NCT06623461","url":"https://clinicaltrials.gov/study/NCT06623461"}],"tags":[],"related":["idea-bio2-fmt-plus-checkpoint-phase3"],"cancers":["melanoma"],"sections":["nutrition-lifestyle","immunotherapy"],"technologies":["fmt-checkpoint-nonresponders","microbiome-modulation-io","checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","pembrolizumab"],"companies":[],"institutions":[],"pathways":["microbiome-tumour"],"terms":["gut-microbiome-diversity","orr"],"trials":[],"people":[],"bottlenecks":["b-immunotherapy-response"],"keyPapers":["paper-mimic-01-nat-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03772899","phase":"1","setting":"Untreated advanced melanoma: oral capsule FMT from healthy donors one week before, then with, nivolumab or pembrolizumab","sponsor":"Centre hospitalier de l'Universite de Montreal / Lawson Health Research Institute","result":"ORR 65% (13 of 20), 4 complete responses; no FMT-related serious adverse events.","started":"2019-03-27","startedType":"actual","yearReported":2023,"enrolled":20,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"FMT + anti-PD-1","n":20,"value":65}],"source":"https://doi.org/10.1038/s41591-023-02453-x"}],"replication":"Randomised phase 2 (LND101, NCT06623461) recruiting."},"route":"/trials/mimic-01/","neighbours":{"idea":[{"id":"idea-bio2-fmt-plus-checkpoint-phase3","kind":"idea","name":"Take faecal transplant plus immunotherapy to a definitive trial","route":"/ideas/idea-bio2-fmt-plus-checkpoint-phase3/"}],"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"section":[{"id":"nutrition-lifestyle","kind":"section","name":"Diet, Exercise & Lifestyle","route":"/fronts/nutrition-lifestyle/"},{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"fmt-checkpoint-nonresponders","kind":"technology","name":"Faecal microbiota transplantation for PD-1 non-responders","route":"/technologies/fmt-checkpoint-nonresponders/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"microbiome-modulation-io","kind":"technology","name":"Microbiome modulation to unlock immunotherapy","route":"/technologies/microbiome-modulation-io/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"pathway":[{"id":"microbiome-tumour","kind":"pathway","name":"Microbiome-tumour interactions","route":"/pathways/microbiome-tumour/"}],"term":[{"id":"gut-microbiome-diversity","kind":"term","name":"Gut microbiome diversity and composition","route":"/terms/gut-microbiome-diversity/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"bottleneck":[{"id":"b-immunotherapy-response","kind":"bottleneck","name":"No one can predict who responds to immunotherapy","route":"/bottlenecks/b-immunotherapy-response/"}],"paper":[{"id":"paper-mimic-01-nat-med-2023","kind":"paper","name":"Fecal microbiota transplantation plus anti-PD-1 immunotherapy in advanced melanoma: a phase I trial","route":"/key-papers/paper-mimic-01-nat-med-2023/"}],"roadmap":[{"id":"nutrition-lifestyle-roadmap","kind":"roadmap","name":"Diet, exercise and lifestyle roadmap: causes established → interventions that disappointed → exercise proven as treatment","route":"/roadmaps/nutrition-lifestyle-roadmap/"}]}}