Negative / Null Result ReportOpen accessMedicine· cited by 473

Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial

Nazlı Dizman; Luís Meza; Paulo Gustavo Bergerot; Marice Alcantara; Tanya B. Dorff; Yung Lyou; Paul Frankel; Yujie Cui · 2022 · Nature Medicine

WASTE classifies this as Negative / Null Result Report · AI classification, approximate

The study found no significant effect — useful as a negative control or null benchmark for your own design.

Abstract

Previous studies have suggested that the gut microbiome influences the response to checkpoint inhibitors (CPIs) in patients with cancer. CBM588 is a bifidogenic live bacterial product that we postulated could augment CPI response through modulation of the gut microbiome. In this open-label, single-center study (NCT03829111), 30 treatment-naive patients with metastatic renal cell carcinoma with clear cell and/or sarcomatoid histology and intermediate- or poor-risk disease were randomized 2:1 to receive nivolumab and ipilimumab with or without daily oral CBM588, respectively. Stool metagenomic s

Abstract by Nazlı Dizman; Luís Meza; Paulo Gustavo Bergerot; Marice Alcantara; Tanya B. Dorff; Yung Lyou; Paul Frankel; Yujie Cui, Nature Medicine (2022) — licensed CC BY 4.0.

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