Table 3.
Clinical trials of probiotics and engineered microbiomes in combination with ICIs in cancer treatment www.clinicaltrials.gov
| NCT number | Cancer types | n | Microbiome-based therapy | Intervention | Stage | References |
|---|---|---|---|---|---|---|
| NCT03775850 | Solid tumors | 120 | EDP1503 (Bifidobacterium strain) | EDP1503 (capsules) + Pembrolizumab | Phase 1–2 | [144] |
| NCT03637803 | Solid tumors | 132 | MRx0518 (E. gallinarum strain) | MRx0518 (capsules) + Pembrolizumab | Phase 1–2 | – |
| NCT05107427 | Urothelial carcinoma | 30 | MRx0518 (E. gallinarum strain) | MRx0518 (capsules) + Avelumab | Phase 2 | – |
| NCT03686202 | Solid tumors | 65 | MET-4 (Mixture of pure live cultures of intestinal bacteria) | MET (capsules) + ICI | Phase 1 | – |
| NCT04601402 | Solid tumors | 93 | GEN-001 (Lactococcus lactis strain) | GEN-001 (capsules) + Avelumab | Phase 1 | – |
| NCT04187404 | Adrenal tumors | 60 | EO2401 (Vaccines of microbial-derived peptide homologous to tumor-associated antigens) | EO2401 + Nivolumab | Phase 1–2 | – |
| NCT04116658 | Glioblastoma | 52 | EO2401 (Vaccines of microbial-derived peptide homologous to tumor-associated antigens) | EO2401 + Nivolumab | Phase 1–2 | – |
| NCT03829111 | Renal cell carcinoma | 30 | CBM588 (Clostridium butyricum probiotic) | Nivolumab + Ipilimumab versus CBM588 (capsules) + Nivolumab + Ipilimumab | Phase 1 | [145] |
| NCT04167137 | Solid neoplasm, lymphoma | 70 | SYNB1891 (Engineered E. coli) | SYNB1891 (intratumoral injection) + Atezolizumab | Phase 1 | – |
| NCT04208958 | Solid tumors | 54 | VE800 (11 commensal bacterial strains) | VE800 + Nivolumab | Phase 1–2 | – |
| NCT03817125 | Melanoma | 14 | SER-401 (Defined bacterial consortia) | SER-401 (capsules) + Nivolumab versus Placebo + Nivolumab | Phase 1 | – |
ICI: immune checkpoint inhibitor; n: number of patients