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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
15 treated.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Clinical benefit (objective response or SD over 12 months)primary | FMT + pembrolizumab | 15 | 40% | - | - | link |
One trial page, one technology page, one pathway page and one idea page on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
One trial page and one idea page on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
Shares Take faecal transplant plus immunotherapy to a definitive trial, Microbiome modulation to unlock immunotherapy, Gut microbiome diversity and composition, Faecal microbiota transplantation for PD-1 non-responders.
Shares Microbiome modulation to unlock immunotherapy, Gut microbiome diversity and composition, Faecal microbiota transplantation for PD-1 non-responders, Microbiome-tumour interactions.
Shares Microbiome modulation to unlock immunotherapy, Gut microbiome diversity and composition, Microbiome-tumour interactions, Diet, exercise and lifestyle roadmap: causes established → interventions that disappointed → exercise proven as treatment.
Shares Gut microbiome diversity and composition, Microbiome transplant as a routine immunotherapy adjunct, Microbiome-tumour interactions.
Shares Gut microbiome diversity and composition, No one can predict who responds to immunotherapy, Melanoma, Pembrolizumab.
Shares Take faecal transplant plus immunotherapy to a definitive trial, Faecal microbiota transplantation for PD-1 non-responders, Immune checkpoint inhibitors.
Shares No one can predict who responds to immunotherapy, Melanoma, Pembrolizumab, Immune checkpoint inhibitors.
Shares Objective response rate (ORR), No one can predict who responds to immunotherapy, Melanoma, Immune checkpoint inhibitors.