The role of the tumor microbe microenvironment in the tumor immune microenvironment: bystander, activator, or inhibitor?

Table 2 Clinical trials of the probiotic and immune checkpoint blockade combination registered on NIH ClinicalTrials.gov

NCT number	Probiotic	Immune checkpoint inhibitor	Disease	Design
NCT03775850	EDP1503	Pembrolizumab	MSS colorectal cancer, triple negative breast cancer, and PD-1 blockade relapsed cancer	Phase I/II, open-label, triple-cohort, non-randomized
NCT03595683	EDP1503	Pembrolizumab	Advanced melanoma naïve or refractory to PD-1 blockade	Phase II, dual-cohort, non-randomized
NCT03637803	MRx0518	Pembrolizumab	Advanced and/or metastatic or recurrent cancer, including NSCLC, renal cell carcinoma, bladder cancer, and melanoma	Phase I/II, open-label, one-cohort non-randomized
NCT04208958	VE800	Nivolumab	Advanced or metastatic cancer, including melanoma, gastric cancer, gastroesophageal junction adenocarcinoma, and MSS colorectal cancer	Phase I/II, multicenter, open-label, one-cohort, non-randomized
NCT03817125	SER-401	Nivolumab	PD-1 blockade naive, unresectable or metastatic melanoma	Phase Ib, multicenter, randomized, placebo-controlled, blinded
NCT04601402	GEN-001	Avelumab	Locally advanced or metastatic solid tumors which have progressed on PD-1/PD-L1 blockade, including NSCLC, squamous cell carcinoma of head and neck, and urothelial carcinoma	Phase I/Ib, dual-cohort, non-randomized

Abbreviations: MSS Microsatellite stable, NSCLC Nonsmall-cell lung cancer, PD-1 Programmed cell death protein-1, PD-L1 Programmed cell death protein-ligand 1

ISSN: 1756-9966