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 | – |