Table 2.
The ongoing clinical trials aimed to investigate the role of the intestinal microbiome modulation in ICI therapy
| 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 | – |
AEs, adverse events; FMT, fecal microbiota transplantation; GI, Gastrointestinal; ICI, immune checkpoint inhibitor; PFS, progression-free survival