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Table 2 The ongoing clinical trials aimed to investigate the role of the intestinal microbiome modulation in ICI therapy

From: Role of the intestinal microbiome and microbial-derived metabolites in immune checkpoint blockade immunotherapy of cancer

NCT number Disease Patient (n) Brief study description Primary endpoints Enrollment status Study phase
NCT04552418 Solid tumor 12 Pilot study of intestinal microbiome modification with potato starch supplement in cancer patients treated with a dual ICIs Percentage of patients able to adhere to treatment
Serious AEs
Not yet recruiting 1
NCT04107168 Melanoma
Renal cancer
Lung cancer
1800 Observational study to investigate how the microbiome correlates with efficacy and toxicity of ICIs PFS Recruiting
NCT03819296 Cutaneous melanoma
Malignant genitourinary system neoplasm
Malignant solid neoplasm
Lung cancer
800 The study to evaluate the role of the intestinal microbiome and efficacy of FMT on ICI-associated GI complications The intestinal microbiome
Incidence of AEs of FMT
Recruiting 1/2
NCT04204434 Advanced cancer
150 The study to explore biomarkers for ICIs such as serum predictors, bacteria, or bacterial products in the intestinal microbiome Serum predictors of response to ICIs Recruiting
NCT04579978 Advanced solid tumor 60 The study to examine potential mechanisms by which gut bacteria in the intestinal microbiome impact on ICI response The intestinal microbiome-associated ICI response
The intestinal microbiome-associated ICI toxicity
NCT04038619 Colitis
Malignant genitourinary system neoplasm
40 The trial to study how well FMT works in treating ICI-associated colitis Incidence of FMT-related AEs
Clinical response or remission of colitis
Recruiting 1
NCT04758507 Renal cell carcinoma 50 The study to evaluate the efficacy of targeted FMT PFS Recruiting 1/2
NCT04189679 Non-small cell lung cancer 60 The study to identify predictive metabolic, metagenomic, and immune signature of ICI response The change of metabolic signature Recruiting
  1. AEs, adverse events; FMT, fecal microbiota transplantation; GI, Gastrointestinal; ICI, immune checkpoint inhibitor; PFS, progression-free survival