OnCo
ideasIdea

Microbiome transplant as a routine immunotherapy adjunct

Stool transplants from immunotherapy responders have rescued some non-responders in melanoma. If defined bacterial cocktails work as well, every immunotherapy patient could get one.

Phase 1/2 FMT studies (Davar, Baruch) converted 20-40% of refractory melanoma patients; defined consortia (SER-155, VE800) and diet trials are ongoing; mechanisms and durability are unclear.

Hypothesis
A defined bacterial consortium given with first-line PD-1 blockade increases response rate in melanoma and NSCLC compared with placebo, with effect size dependent on baseline microbiome composition.
Rationale
Consistent associations across cohorts, causal FMT data, and the fact that antibiotics worsen outcomes.
What would test it
Placebo-controlled phase 2/3 of a consortium plus PD-1 in first-line melanoma with stratification by baseline microbiome, endpoints ORR and PFS.
Maturity
early clinical

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