Table 1.
Ongoing Cancer Clinical Trials Investigating Gut Microbiome Interventions and Immunotherapy
| ClinicalTrials.gov no. | Phase | Cancer type | Intervention | Investigator | Status |
|---|---|---|---|---|---|
| FMT interventions | |||||
| NCT03772899 | I | Melanoma | FMT + immune checkpoint inhibitors | Lawson Health Research Institute | Recruiting |
| NCT03353402 | I | Melanoma | FMT (via colonoscopy and stool capsules) + immune checkpoint inhibitors | Sheba Medical Center | Recruiting |
| NCT03341143 | II | Melanoma | FMT (via colonoscopy) + immune checkpoint inhibitors | UPMC Hillman Cancer Center | Suspended due to COVID-19 |
| NCT04577729 | – | Melanoma | Autologous or allogeneic FMT + immune checkpoint inhibitors | Medical University of Graz | Not yet recruiting |
| NCT04521075 | I/II | Melanoma NSCLC | FMT (stool capsules) + immune checkpoint inhibitors | Sheba Medical Center | Not yet recruiting |
| NCT04056026 | I | Mesothelioma | FMT (via colonoscopy) + immune checkpoint inhibitors | ProgenaBiome | Completed |
| NCT04116775 | II | Prostate | FMT (via endoscopy) + immune checkpoint inhibitors + enzalutamide | VA Portland Health Care System | Recruiting |
| NCT04130763 | I | Gastrointestinal | FMT (stool capsules) + immune checkpoint inhibitors | Peking University | Recruiting |
| Non-FMT microbiome interventions | |||||
| NCT03686202 | I | Solid tumors | MET-4 (defined bacterial consortia) + immune checkpoint inhibitors | University Health Network, Toronto | Recruiting |
| NCT03817125 | I | Melanoma | SER-401 (defined bacterial consortia) + immune checkpoint inhibitors | Parker Institute for Cancer Immunotherapy | Recruiting |
| NCT03637803 | I/II | Solid tumors | MRx0518 (E. gallinarum capsule) + immune checkpoint inhibitors | 4D pharma plc | Recruiting |
| NCT03775850 | I/II | Solid tumors | EDP1503 (Bifidobacterium capsule) + immune checkpoint inhibitors | Evelo Biosciences | Recruiting |
| NCT03595683 | II | Melanoma | EDP1503 (Bifidobacterium capsule) + immune checkpoint inhibitors | Evelo Biosciences | Active, not recruiting |
| NCT03829111 | I | Renal cell carcinoma | CBM 588 (Clostridium butyricum probiotic) + immune checkpoint inhibitors | City of Hope Medical Center | Recruiting |
COVID-19, coronavirus 2019; NSCLC, non–small cell lung cancer; UPMC, University of Pittsburgh Medical Center; VA, Veterans Affair.