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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

Colitis

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

Neoplasms

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

Recruiting

–

NCT04038619

Colitis

Diarrhea

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