FMT plus pembrolizumab in anti-PD-1-refractory melanoma (Pittsburgh)
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.
- 40 out of 100 people had their tumour shrink with FMT + pembrolizumab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Metastatic melanoma with primary resistance to anti-PD-1: single colonoscopic FMT from a durable responder donor, then pembrolizumab. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PD-1); the result should not be assumed for people whose cancer does not have it.
- Only 15 people took part, so the numbers are less certain than in a large trial.
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 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Clinical benefit (objective response or SD over 12 months)primary | FMT + pembrolizumab | 15 | 40% | — | — | link |
Pages like this
not linked directly; found by shared links- TrialMIMic-01: healthy-donor FMT plus anti-PD-1, first-line melanoma
Shares Gut microbiome diversity and composition, Take faecal transplant plus immunotherapy to a definitive trial, Microbiome modulation to unlock immunotherapy, Faecal microbiota transplantation for PD-1 non-responders.
- TechnologyProbiotics, antibiotics and stewardship around immunotherapy
Shares Gut microbiome diversity and composition, Microbiome modulation to unlock immunotherapy, Microbiome–tumour interactions, No one can predict who responds to immunotherapy.
- TechnologyDietary fibre and the gut microbiome for immunotherapy response
Shares Gut microbiome diversity and composition, Microbiome modulation to unlock immunotherapy, Faecal microbiota transplantation for PD-1 non-responders, Microbiome–tumour interactions.
- TermHallmark (2022): polymorphic microbiomes
Shares Microbiome transplant as a routine immunotherapy adjunct, Gut microbiome diversity and composition, Microbiome–tumour interactions.
- InstitutionCentre hospitalier de l'Université de Montréal (CHUM)
Shares Microbiome modulation to unlock immunotherapy, No one can predict who responds to immunotherapy, Melanoma, Immune checkpoint inhibitors.
- IdeaRandomise a cheap antihistamine alongside immunotherapy
Shares No one can predict who responds to immunotherapy, Pembrolizumab, Melanoma, Immune checkpoint inhibitors.
- IdeaCapture diet, fibre and antibiotic exposure in every immunotherapy pivotal trial
Shares Gut microbiome diversity and composition, No one can predict who responds to immunotherapy, Pembrolizumab, Melanoma.
- PersonTasuku Honjo
Shares No one can predict who responds to immunotherapy, Pembrolizumab, Melanoma, Immune checkpoint inhibitors.