OnCo
ideasIdea

Take faecal transplant plus immunotherapy to a definitive trial

Transferring gut bacteria from patients who responded to immunotherapy has helped some patients who had stopped responding. It is time for a proper large trial.

Two independent phase 1 studies reported that faecal microbiota transplant from checkpoint responders re-sensitised some anti-PD-1-refractory melanoma patients, and a first-line study of donor transplant with checkpoint blockade showed feasibility and encouraging response. The field has stayed in small single-arm studies for years. A randomised trial with a defined donor consortium, standardised product and pre-specified microbiome endpoints would settle whether the effect is real.

Hypothesis
Faecal microbiota transplant from selected responder donors plus anti-PD-1 improves response rate compared with anti-PD-1 alone in checkpoint-refractory melanoma, with engraftment of donor taxa as a mechanistic mediator.
Rationale
The mouse causal data are strong, human phase 1 signals are reproducible across two centres, and the intervention is inexpensive. The main risks are donor variability and product standardisation, both addressable through consortium banking.
What would test it
A randomised phase 2 with pooled standardised donor product, primary endpoint objective response, and mandatory metagenomic sequencing to link engraftment with response.
Maturity
early clinical
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
5
Bottlenecks it attacks

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