Table 2.

Clinical trials of FMT modulate the efficacy and AEs of ICI www.clinicaltrials.gov

NCT number	Cancer types	n	Intervention	Outcome(s)	Stage	References
Modulation of the gut microbiome to improve ICI efficacy
NCT04056026	Mesothelioma	1	FMT + Pembrolizumab	PFS	Phase 1	–
NCT04521075	Melanoma, NSCLC	50	FMT + Nivolumab	FMT-related AEs, ORR	Phase 1–2	–
NCT04130763	Gastrointestinal	10	FMT + Anti-PD-1	FMT-related AEs, ORR	Phase 1	–
NCT04116775	Prostate	32	FMT + Enzalutamide + Pembrolizumab	Anticancer effect	Phase 2	–
NCT04729322	dMMR CRC	15	FMT + Pembrolizumab–Nivolumab	ORR	Phase 1	–
NCT04577729	Melanoma	60	Allogenic FMT + ICI versus Autologous FMT + ICI	PFS	NA	–
NCT04758507	RCC	50	Donor FMT + ICI versus Placebo FMT + ICI	PFS	Phase 1–2	–
NCT04924374	NSCLC	20	Anti-PD-1 + FMT versus Anti-PD-1	Treatment safety and responses	NA	–
NCT04988841	Melanoma	60	MaaT013 + Ipilimumab + Nivolumab versus placebo + Ipilimumab + Nivolumab	AE, ORR	Phase 2	–
NCT03772899	Melanoma	20	FMT + Pembrolizumab/Nivolumab	Safety, ORR	Phase 1	–
NCT03341143	Melanoma	20	FMT + Pembrolizumab	ORR	Phase 2	[14]
NCT03353402	Melanoma	40	FMT + ICI	FMT-related AEs,	Phase 1	[15]
Modulation of the gut microbiome to prevent ICI-related AEs
NCT04038619	RCC	40	Loperamide + FMT + ICI	FMT-related AEs, ICI-related diarrhea/colitis	Phase 1	–
NCT04163289	Renal cancer	20	FMT + Nivolumab/Ipilimumab	Immune-related colitis	Phase 1	–
NCT03819296	Solid tumors	800	FMT + Infliximab/Vedolizumab	FMT-related AEs, ICI-related colitis	Phase 1–2	–
NCT04883762	Solid tumors	10	FMT + ICI	FMT-related AEs, ICI-related diarrhea	Phase 1	–

AEs: adverse events; CRC: colorectal cancer; dMMR: mismatch-repair deficiency; FMT: fecal microbiota transplant; ICI: immune checkpoint inhibitor; n: number of patients; NA: not applicable; NSCLC: non-small cell lung cancer; ORR: objective responses rate; PFS: progression-free survival; and RCC: renal cell carcinoma