Table 1:

Ongoing clinical trials evaluating the role of microbiome in cancer immunotherapy and other select cancer treatments.

ID	Phase	Indication	Design	Main Outcome Measure	Direct Microbiome Intervention	Status
NCT04264975	Phase I	Solid Cancer	Evaluation of FMT in modulating efficacy of immune therapy	ORR*	FMT***	Recruiting
NCT04130763	Phase 1	Gastrointestinal cancer	Evaluation of FMT in improving the efficacy of anti-PD-1 therapy	ORR	FMT	Recruiting
NCT04163289	Phase 1	Renal Cell Carcinoma	Evaluation of FMT in prevention of immune-related colitis	Immune-related colitis incidence and severity	FMT	Recruiting
NCT04116775	Phase 2	Prostate cancer	Evaluation of FMT in improving the efficacy of anti-PD-1 therapy	ORR	FMT	Recruiting
NCT03819296	Phase 1	Melanoma GU cancer	Evaluation of FMT in treatment of immune-related colitis	Immune-related colitis incidence and severity	FMT	Not yet recruiting
NCT03353402	Phase 1	Melanoma	Evaluation of FMT in treatment potentiation in patients who failed anti-PD-1 therapy	ORR	FMT	Recruiting
NCT03341143	Phase 2	Melanoma	Evaluation of FMT in improving the efficacy of anti-PD-1 therapy	ORR	FMT	Recruiting
NCT03688347	Observational	Lung cancer	Evaluation of the correlation between microbiome and efficacy and safety of immune therapy and other cancer treatments	ORR, adverse event incidence	None	Active, not recruiting
NCT03586297	Observational	Breast cancer	Evaluation of the correlation between microbiome diversity and pathological complete response after neoadjuvant chemotherapy	pCR**	None	Recruiting
NCT03569137	Observational	Hematologic malignancy	Evaluation of the correlation between microbiome biomarkers and ibrutinib-associated colitis	Colitis incidence and severity	None	Not yet recruiting

^*ORR: overall response rate

^**pCR: pathological complete response

^***FMT: fecal microbiota transplant