The gut microbiome can impact immunotherapy response in advanced melanoma. Thus far, fecal transplant trials have been single arm, and remain challenging to adopt widely. In this study, Glitza, Seo, Spencer, and colleagues performed a randomized placebo-controlled microbiome modulation trial in patients with advanced melanoma getting nivolumab. Prior to immunotherapy, the SER-401 arm received vancomycin preconditioning and SER-401, a microbiome-modulation pill enriched in bacteria associated with immunotherapy response; the placebo arm received placebo antibiotics and placebo microbiome. Though nivolumab+SER-401 was well tolerated, the objective response was 25% in the SER-401 arm and 67% in the placebo arm. Vancomycin was associated with gut microbiome disruption and impaired immunity, highlighting the importance of careful consideration for preconditioning in microbiome trials.

See article, p. 1161.

Immune checkpoint inhibitor therapy is approved for first-line treatment of clear cell renal cell carcinoma, but complete responses are rare and the majority of patients ultimately experience disease...

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