# MIMic-01: healthy-donor FMT plus anti-PD-1, first-line melanoma

Source: https://onco.cc/trials/mimic-01/  
OnCo record `mimic-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-08
- Registry id: 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
- Enrolled: 20
- Result: ORR 65% (13 of 20), 4 complete responses; no FMT-related serious adverse events.
- Outcomes: Objective response rate: FMT + anti-PD-1 65%
- Replication: Randomised phase 2 (LND101, NCT06623461) recruiting.

## Sources

- ClinicalTrials.gov NCT03772899: https://clinicaltrials.gov/study/NCT03772899
- Routy et al. (Nat Med 2023): https://doi.org/10.1038/s41591-023-02453-x
- ClinicalTrials.gov NCT06623461: https://clinicaltrials.gov/study/NCT06623461

## Connected records

- ideas: [Take faecal transplant plus immunotherapy to a definitive trial](https://onco.cc/ideas/idea-bio2-fmt-plus-checkpoint-phase3/)
- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- fronts: [Diet, Exercise & Lifestyle](https://onco.cc/fronts/nutrition-lifestyle/), [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- technologies: [Faecal microbiota transplantation for PD-1 non-responders](https://onco.cc/technologies/fmt-checkpoint-nonresponders/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Microbiome modulation to unlock immunotherapy](https://onco.cc/technologies/microbiome-modulation-io/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- pathways: [Microbiome-tumour interactions](https://onco.cc/pathways/microbiome-tumour/)
- terms: [Gut microbiome diversity and composition](https://onco.cc/terms/gut-microbiome-diversity/), [Objective response rate (ORR)](https://onco.cc/terms/orr/)
- bottlenecks: [No one can predict who responds to immunotherapy](https://onco.cc/bottlenecks/b-immunotherapy-response/)
- key papers: [Fecal microbiota transplantation plus anti-PD-1 immunotherapy in advanced melanoma: a phase I trial](https://onco.cc/key-papers/paper-mimic-01-nat-med-2023/)
- roadmaps: [Diet, exercise and lifestyle roadmap: causes established → interventions that disappointed → exercise proven as treatment](https://onco.cc/roadmaps/nutrition-lifestyle-roadmap/)

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