MIMic-01: healthy-donor FMT plus anti-PD-1, first-line melanoma
Twenty melanoma patients took stool capsules from healthy donors before starting immunotherapy. Thirteen responded, more than usually expected, and the transplant was safe.
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.
- 65 out of 100 people had their tumour shrink with FMT + anti-PD-1.
- 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: Untreated advanced melanoma: oral capsule FMT from healthy donors one week before, then with, nivolumab or pembrolizumab. People in a different situation may not see the same effect.
- Only 20 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.
Pages like this
not linked directly; found by shared links- TrialFMT plus pembrolizumab in anti-PD-1-refractory melanoma (Pittsburgh)
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.
- PersonTasuku Honjo
Shares No one can predict who responds to immunotherapy, Nivolumab, Pembrolizumab, Melanoma.
- 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, Nivolumab, Pembrolizumab.
- 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.
- Key paperTopalian 2012: the first large trial of a PD-1 antibody shows durable responses across melanoma, lung and kidney cancer
Shares Objective response rate (ORR), No one can predict who responds to immunotherapy, Nivolumab, Pembrolizumab.