articleNature MedicineFeb 28, 2022HYBRID OA

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

NDNazlı DizmanLMLuís MezaPGPaulo Gustavo BergerotMAMarice AlcantaraTBTanya B. Dorff

Yale University · City of Hope · +3 more institutions

PubMed
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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 sequencing was performed at multiple timepoints. The primary endpoint to compare the relative abundance of…

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Topics & keywords

Topics
Keywords
  • Nivolumab
  • Ipilimumab
  • Medicine
  • Internal medicine
  • Clinical endpoint
  • Hazard ratio
  • Oncology
  • Renal cell carcinoma
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