NCT04264975 - Fecal microbiota transplantation (FMT) & Solid tumors

An open-label, non-randomized, single-center clinical trial evaluating fecal microbiota transplantation (FMT) from anti-PD-1 responders in patients whose solid tumors do not respond to ICI treatment.
Park et al. 2023b JCO 41: 105-105

The rationale for this study is based on the potential of the gut microbiome to influence the clinical effectiveness of cancer immunotherapy
Daillère et al. 2020 Oncoimmunology 9(1): 1774298

Primary outcome measures:
Overall Response Rate (ORR)

FMT induced sustained microbiota changes and clinical benefits in 6 of the 13 patients:

• 1 partial response


• 5 stable diseases

This resulted in:

• An objective response rate of 7.7%


• A disease control rate of 46.2%

The clinical response was correlated with:

• Increased cytotoxic T cells


• Elevated immune cytokines in blood and tumo…