Table 2.
Clinical trials of FMT manipulating the gut microbiome in immunotherapy
| Cancer type | Enrollment | Immunotherapy | Microbial intervention | Phase | Location | Status | |
|---|---|---|---|---|---|---|---|
| NCT03341143 | melanoma | 18 | pembrolizumab | FMT via colonoscopy from ICI responders | 2 | USA | active, not recruiting |
| NCT03353402 | melanoma | 40 | anti-PD-1 | FMT capsules from ICI responders | 1 | Israel | unknown |
| NCT03772899 | melanoma | 20 | pembrolizumab/nivolumab | FMT capsules from healthy donors | 1 | Canada | active, not recruiting |
| NCT03819296 | melanoma, genitourinary, malignant solid neoplasm, lung | 800 | ICIs | FMT from healthy donors | 1/2 | USA | recruiting |
| NCT04038619 | genitourinary, melanoma, lung, ovarian, uterine, breast, cervical | 40 | loperamide | FMT via colonoscopy | 1 | USA | recruiting |
| NCT04056026 | mesothelioma | 1 | pembrolizumab (Keytruda) | single-dose FMT infusion | 1 | USA | completed |
| NCT04116775 | prostate | 32 | pembrolizumab | FMT via endoscopy | 2 | USA | recruiting |
| NCT04130763 | gastrointestinal system | 10 | anti-PD-1 | FMT capsules | 1 | China | unknown |
| NCT04163289 | RCC | 20 | ipilimumab+nivolumab | FMT capsules | 1 | Canada | recruiting |
| NCT04264975 | solid carcinoma | 60 | immunotherapy | FMT | N/A | Korea | unknown |
| NCT04521075 | melanoma, NSCLC | 42 | nivolumab | FMT capsules | 1/2 | Israel | unknown |
| NCT04577729 | melanoma | 5 | ICIs | allogenic FMT; autologous FMT | N/A | Austria | terminated |
| NCT04729322 | CRA, small intestinal adenocarcinoma, CRC | 14 | pembrolizumab/nivolumab | FMT capsules | 2 | USA | recruiting |
| NCT04758507 | RCC | 50 | ICIs | FMT capsules | 1/2 | Italy | recruiting |
| NCT04883762 | solid tumors | 4 | ICIs | FMT via colonoscopy | 1 | USA | active, not recruiting |
| NCT04924374 | lung cancer | 20 | pembrolizumab, nivolumab, atezolizumab | FMT capsules | N/A | Spain | recruiting |
| NCT04951583 | NSCLC, melanoma | 70 | pembrolizumab, ipilimumab+nivolumab | investigational FMT capsules | 2 | Canada | recruiting |
| NCT04988841 | melanoma | 60 | ipilimumab+nivolumab | fecal microbiotherapy (MaaT013): pooled-donor, full-ecosystem intestinal microbiome | 2 | France | recruiting |
| NCT05008861 | NSCLC | 20 | anti-PD-1/PD-L1 | FMT capsules | 1 | China | unknown |
| NCT05251389 | melanoma | 24 | ICIs | FMT from ICI non-responders/responders | 1/2 | Netherlands | recruiting |
| NCT05273255 | malignancies | 30 | ICIs | FMT via endoscopy | N/A | Switzerland | recruiting |
| NCT05279677 | CRC | 30 | sintilimab+fruquintinib | FMT | 2 | China | recruiting |
| NCT05286294 | melanoma, HNSCC, CSCC, MSI-high, clear cell RCC, NSCLC | 20 | ICIs | FMT | 2 | Norway | recruiting |
| NCT05502913 | lung | 80 | ICIs | FMT capsules | 2 | Israel | recruiting |
| NCT05690048 | liver | 48 | atezolizumab+bevacizumab | FMT capsules | 2 | Germany | not recruiting |
| NCT05750030 | HCC | 12 | atezolizumab+bevacizumab | FMT | 2 | Austria | recruiting |
CRA, colorectal adenocarcinoma; HNSCC, head and neck squamous cell carcinoma; CSCC, cutaneous squamous cell carcinoma.