Table 3.
Clinical trials linking gut microbiota and cancer immunotherapy.
| Interventions | Trial number | Conditions | Major microbiota and immune related outcomes | Phases |
|---|---|---|---|---|
| FMT | ||||
| FMT via colonoscopy | NCT04264975 | Solid carcinoma | Response to immunotherapy plus FMT | Not applicable |
| FMT via colonoscopy | NCT04056026 | Mesothelioma | Response to Keytruda plus FMT | Early Phase 1 |
| FMT via colonoscopy | NCT03772899 | Melanoma | Response to immunotherapy plus FMT | Phase 1 |
| FMT via endoscopy | NCT04116775 | Metastatic castration-resistant prostate cancer | Response to pembrolizumab plus FMT | Phase 2 |
| FMT via oral capsule | NCT04130763 | Gastrointestinal system cancer | Response to anti-PD-1 plus FMT | Phase 1 |
| FMT via oral capsule | NCT04521075 | Metastatic melanoma or NSCLC | Response to nivolumab plus FMT | Phase 1/Phase 2 |
| FMT via colonoscopy and oral capsule | NCT03353402 | Melanoma Stage IV and unresectable Stage III | Response to immunotherapy plus FMT | Phase 1 |
| FMT | NCT04577729 | Melanoma Stage III and IV | Response to checkpoint inhibitor plus FMT | Not applicable |
| FMT via colonoscopy | NCT03341143 | PD-1 resistant/refractory melanoma | Response to checkpoint inhibitor plus FMT | Phase 2 |
| Diet | ||||
| Fasting mimicking diet | NCT03454282 | Breast cancer or melanoma | Tumor-infiltrating lymphocytes, gut microbiota composition | Not applicable |
| Dietary supplement: IGEN0206 | NCT04009122 | Non-small cell lung cancer metastatic | Quality of life, changes in the microbiota, interleukin levels, cytokines levels | Not applicable |
| Probiotics | ||||
| Oral Primal Defense Ultra Probiotic Formula | NCT03358511 | Breast cancer | Mean number of cytotoxic T cell | Not applicable |
| Oral MRx0518 | NCT04193904 | Pancreatic cancer | Tumor infiltrating lymphocytes | Phase 1 |
| 5 | NCT03817125 | Metastatic melanoma | Response to checkpoint inhibitor | Phase 1 |
| Oral MET-4 | NCT03838601 | Head and neck squamous cell carcinoma | Bacterial composition and diversity, blood immune cell profiling | not applicable |
| Oral BB536, LA1 | NCT00936572 | Colorectal cancer | Immune and inflammatory response, bacterial translocation | Phase 2 |
| IV JNJ-64041809 | NCT02625857 | Metastatic castration-resistant prostate cancer | Immune responses | Phase 1 |
| Oral MRx0518 | NCT03637803 | Solid tumors | Clinical benefit of MRx0518 in combination with pembrolizumab | Phase 1/Phase 2 |
| Oral RBX7455 | NCT04139993 | Breast cancer | Intratumoral immunomodulatory | Early Phase 1 |
| Oral GEN-001 | NCT04601402 | Solid tumors | Response to avelumab | Phase 1 |
| Oral EDP1503 | NCT03595683 | Melanoma | Response to pembrolizumab | Phase 2 |
| Oral MET-4 | NCT03686202 | Solid tumors | Relative abundance of immunotherapy-responsiveness associated species of MET-4 | Early Phase 1 |
| Oral VE800 | NCT04208958 | Selected types of advanced or metastatic cancer | Safety and efficacy of VE800 in combination with nivolumab | Phase 1/Phase 2 |
| Oral MRx0518 | NCT03934827 | Solid tumors | Safety, tolerability, and immune system modulation of MRx0518 | Phase 1 |
| Oral EDP1503 | NCT03775850 | Colorectal cancer, breast cancer, and checkpoint inhibitor relapsed tumors | Safety, tolerability, and efficacy of EDP1503 alone and in combination with pembrolizumab | Phase 1/Phase 2 |
| Antibiotic | ||||
| Oral vancomycin | NCT03785210 | Refractory primary hepatocellular carcinoma or liver-dominant metastatic cancer from colorectal or pancreatic cancers | Response to nivolumab | Phase 2 |
FMT, fecal microbiota transplant; NSCLC, non-small cell lung carcinoma.