# Microbiome modulation to unlock immunotherapy

Source: https://onco.cc/technologies/microbiome-modulation-io/  
OnCo record `microbiome-modulation-io` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Changing the gut bacteria of a patient whose immunotherapy stopped working, in the hope of restarting the response.

## Summary

Gut composition predicts checkpoint-inhibitor response across cohorts, and small single-arm studies of faecal transplant from responders reported that a minority of refractory melanoma patients regained response. Randomised work is now running: LND101 with checkpoint blockade in advanced melanoma (NCT06623461, phase 2, Canadian Cancer Trials Group), an Oslo phase 2 using responder stool (NCT05286294), and a Netherlands Cancer Institute study (NCT05251389). Defined bacterial consortia are being developed as an alternative to whole stool.

## Fields

- Kind: Technology
- Status: phase-2
- Last checked: 2026-09-08
- Tags: frontier; promising
- Principle: Transferring or supplementing gut commensals alters antigen presentation, systemic interferon tone, and intratumoural T-cell infiltration, restoring sensitivity to PD-1 blockade.
- Strengths: Cheap and repeatable; Targets the host, so it is tumour-genotype agnostic; Randomised trials now running
- Limitations: Donor variability and transmission risk with whole stool; Effect sizes uncertain; no phase 3; Antibiotics and diet confound everything

## Sources

- LND101 + ICB phase 2 (NCT06623461): https://clinicaltrials.gov/study/NCT06623461
- Oslo FMT phase 2 (NCT05286294): https://clinicaltrials.gov/study/NCT05286294

## Connected records

- roadmaps: [Diet, exercise and lifestyle roadmap: causes established → interventions that disappointed → exercise proven as treatment](https://onco.cc/roadmaps/nutrition-lifestyle-roadmap/), [Radical oncology: what could change the war by 2035](https://onco.cc/roadmaps/frontier-2035/)
- cancers: [Melanoma](https://onco.cc/cancers/melanoma/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- fronts: [Diet, Exercise & Lifestyle](https://onco.cc/fronts/nutrition-lifestyle/), [Immunotherapy](https://onco.cc/fronts/immunotherapy/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [Dietary fibre and the gut microbiome for immunotherapy response](https://onco.cc/technologies/dietary-fibre-microbiome-io/), [Faecal microbiota transplantation for PD-1 non-responders](https://onco.cc/technologies/fmt-checkpoint-nonresponders/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Probiotics, antibiotics and stewardship around immunotherapy](https://onco.cc/technologies/probiotics-antibiotic-stewardship-io/)
- terms: [Gut microbiome diversity and composition](https://onco.cc/terms/gut-microbiome-diversity/), [Hot vs cold tumours](https://onco.cc/terms/cold-vs-hot/), [Immune-mediated colitis and diarrhoea](https://onco.cc/terms/immune-colitis/)
- trials: [FMT plus pembrolizumab in anti-PD-1-refractory melanoma (Pittsburgh)](https://onco.cc/trials/fmt-pd1-refractory-melanoma-pitt/), [MIMic-01: healthy-donor FMT plus anti-PD-1, first-line melanoma](https://onco.cc/trials/mimic-01/)
- institutions: [Centre hospitalier de l'Université de Montréal (CHUM)](https://onco.cc/institutions/chum/), [University of Chicago Medicine Comprehensive Cancer Center](https://onco.cc/institutions/uchicago-cancer/), [UPMC Hillman Cancer Center](https://onco.cc/institutions/upmc-hillman/)

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