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Table 3 Clinical trials of probiotics and engineered microbiomes in combination with ICIs in cancer treatment www.clinicaltrials.gov

From: Gut microbiota influence immunotherapy responses: mechanisms and therapeutic strategies

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

–

  1. ICI: immune checkpoint inhibitor; n: number of patients