Table 4 Clinical trials involving fecal microbiota transplantation

TACITO trial

Metastatic renal cell carcinoma

FMT + Immunotherapy + Chemotherapy (anti PD-1/PD-L1 + VEGFR-TKIs)

Preliminary results suggest FMT may improve response to pembrolizumab plus axitinib. 1-year PFS rate was 66.7% with FMT vs. 35.0% with placebo. ORR was 52% with FMT vs 28% with placebo

2

NCT04758507

[246]

FMT-LUMINATE

Non-small cell lung cancer

FMT + Immunotherapy (pembrolizumab)

irAE occurred in 79% patients. Out of 20 patients, ORR was 77% in 14 patients. Final ORR not yet available as the study is ongoing

2

NCT04951583

[171]

FMT-LUMINATE

Melanoma

FMT + Immunotherapy (ipilimumab and nivolumab)

irAE occurred in 80% patients and ORR was 70%

2

NCT04951583

[170]

MITRIC

Solid tumors (melanoma, head and neck cancer, renal clear cell carcinoma, non-small cell lung cancer)

FMT + Immunotherapy

The study is ongoing. Preliminary data shows that irAE occurred in 3 of 9 patients. One patient showed clinical benefit

2

NCT05286294

[247]

CBM588 study

Metastatic renal cell carcinoma

Live bacterial product (CBM588) + Immunotherapy + Chemotherapy (nivolumab + cabozantinib)

ORR was 63% in patients receiving CBM588 + nivolumab + cabozantinib. ORR was 33% if treated with only nivolumab + cabozantinib

1

NCT05122546

[248]

FMT in melanoma patients

Melanoma

FMT + Immunotherapy (Pembrolizumab)

Clinical benefit in 6 out 15 patients. Minimal adverse events and improved ORR

2

NCT03341143

[173]

Utilization of microbiome as biomarkers and therapeutics in immuno-oncology

Solid cancers (gastrointestinal cancers, including GC, ESCC, and HCC)

FMT + Immunotherapy

Clinical benefit in 6 out of 13 patients. Responders showed increased abundance of beneficial microbial taxa, enhanced CD8 + T cell activation, and reduced interleukin-8-expressing myeloid cells

1

NCT04264975

[64]