# FMT plus pembrolizumab in anti-PD-1-refractory melanoma (Pittsburgh)

Source: https://onco.cc/trials/fmt-pd1-refractory-melanoma-pitt/  
OnCo record `fmt-pd1-refractory-melanoma-pitt` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Fifteen melanoma patients whose immunotherapy had failed received a stool transplant from someone whose immunotherapy had worked, then restarted the drug. Six of them benefited, including three with lasting responses.

## Summary

Single-arm study. Donors were seven melanoma patients with complete or durable partial responses to anti-PD-1. Of 15 recipients, 6 had clinical benefit (3 objective responses, 3 stable disease beyond 12 months); responders showed engraftment of donor taxa, increased CD8 T-cell activation and decreased IL-8-producing myeloid cells, and lower circulating IL-8. A companion Israeli study (Sheba, NCT03353402, 10 patients, 3 responders) was published alongside. Together they were the first human evidence that manipulating the microbiome can reverse checkpoint resistance, and they set off the current wave of randomised FMT and defined-consortium trials. Small, uncontrolled, and with a response rate a sceptic could attribute to re-challenge alone.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-08
- Registry id: NCT03341143
- Phase: 2
- Setting: Metastatic melanoma with primary resistance to anti-PD-1: single colonoscopic FMT from a durable responder donor, then pembrolizumab
- Sponsor: UPMC Hillman Cancer Center / NCI
- Enrolled: 15
- Result: 6 of 15 patients with clinical benefit (3 objective responses).
- Outcomes: Clinical benefit (objective response or SD over 12 months): FMT + pembrolizumab 40%
- Replication: Sheba study (Science 2021) concordant; randomised phase 2 trials (LND101 NCT06623461; Oslo NCT05286294) in progress.

## Sources

- ClinicalTrials.gov NCT03341143: https://clinicaltrials.gov/study/NCT03341143
- Davar et al. (Science 2021): https://doi.org/10.1126/science.abf3363
- Baruch et al., Sheba (Science 2021): https://doi.org/10.1126/science.abb5920

## Connected records

- ideas: [Microbiome transplant as a routine immunotherapy adjunct](https://onco.cc/ideas/idea-microbiome-io-fmt/), [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: [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/)
- people: [Jennifer A. Wargo](https://onco.cc/people/jennifer-wargo/)
- bottlenecks: [No one can predict who responds to immunotherapy](https://onco.cc/bottlenecks/b-immunotherapy-response/)
- key papers: [Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients](https://onco.cc/key-papers/paper-davar-science/), [Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients](https://onco.cc/key-papers/paper-baruch-science/)
- 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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