Long-term clinical outcomes with nivolumab/ipilimumab with or without Clostridium butyricum MIYAIRI588 in metastatic renal cell carcinoma (mRCC): A randomized phase Ib clinical trial
Abstract
4550
Background:
In two randomized phase I trials,
Clostridium butyricum
MIYAIRI588 (CBM588), a live biotherapeutic, demonstrated preliminary activity in modulating the gut microbiome, enhancing systemic immune responses, and improving clinical outcomes in patients receiving first-line nivolumab/ipilimumab and nivolumab/cabozantinib for mRCC (Dizman
et al.
and Ebrahimi
et al.
Nature Medicine). Herein, we present the long-term follow-up data for nivolumab/ipilimumab with or without CBM588.
Methods:
Newly diagnosed patients with mRCC, clear cell and/or sarcomatoid histology, and International mRCC Database Consortium intermediate/high risk were randomized to receive nivolumab/ipilimumab with or without CBM588 in a 2:1 ratio. Response outcomes were assessed using RECIST 1.1. Clinical outcomes were secondary endpoints. Objective response rate (ORR; complete response [CR] or partial response [PR]), disease control rate (DCR; CR, PR, or stable disease [SD] > 6 months), progression-free survival (PFS), and overall survival (OS) outcomes were compared across arms.
Results:
Twenty-nine patients were included in the final analysis: 19 in the nivolumab/ipilimumab with CBM588 arm and 10 in the nivolumab/ipilimumab arm. The median age was 66.2 years, 72% were male, 83% had IMDC intermediate risk and 93% had clear cell histology. Baseline characteristics were similar across arms. ORR and DCR were 58% and 79% in nivolumab/ipilimumab with CBM588 arm versus 20% and 20% in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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