Table 1.
Ongoing clinical trials examining microbial therapeutics alone or in combination with ICI for cancer.
| Clinical trial ID | N = ; study type | Start; estimated completion date | Condition or disease | Intervention |
|---|---|---|---|---|
| NCT03817125* | 10; Phase Ib multicenter SER-401/placebo 2:1 randomised, placebo-controlled, blinded study | January 2019; January 2023 *Discontinued March 2021 due to enrolment impact by COVID19 | Advanced melanoma (unresectable or metastatic) | SER-401 (donor-derived, enriched in Rumminococcacacae) combination treatment with anti-PD-1 ICI nivolumab compared to matching placebo |
| NCT03637803 | 132; Phase I/II Open-label, safety and preliminary efficacy study | January 2019; March 2024 | Anti-PD-1/PD-L1 relapsed advanced solid tumours (NSCLC, RCC, bladder cancer and melanoma) | MRx0518 (Enterococcus gallinarum) combination treatment anti-PD-1 ICI pembrolizumab |
| NCT03934827 | 120; Phase I Safety study; Part A Open-label preliminary safety study; Part B MFx0518/placebo 4:1 randomised, double-blinded study | April 2019; February 2022 | Solid tumours awaiting primary surgical resection | MRx0518 (E. gallinarum) compared to placebo given until surgical resection (Experimental Arm Part B) |
| NCT03775850 | 120; Phase I/II Open-label 3-Cohort study | December 2019; December 2020 | Advanced metastatic CRC, triple-negative breast cancer and ICI relapsed solid tumours | EDP1503 (Bifidobacterium animalis lactus) given alone for 14 days, followed by combination treatment with anti-PD-1 ICI pembrolizumab |
| NCT03595683 | 70; Phase II Dual-Cohort, Open-label study | October 2018; November 2023 | PD-1 relapsed and naive advanced melanoma | EDP1503 (B. animalis lactus) combination treatment with anti-PD-1 ICI pembrolizumab |
| NCT03686202 | 65; Early Phase I Open-label, randomised, feasibility study | September 2018; April 2021 | All solid tumours (locally advanced and metastatic) | MET-4 (defined consortium from donor-derived intestinal bacteria) combination treatment with SOC ICIs |
| NCT04208958 | 111; Phase I/II Open-label single-group assignment study | January 2020; April 2022 | Advanced metastatic cancer; melanoma, gastric/gastroesophageal junction (GEJ) adenocarcinoma, microsatellite-stable (MSS) CRC | VE800 (11 strain defined consortium) combination treatment with anti-PD-1 ICI Nivolumab |
Sourced from Clinicaltrials.gov from the National Library for Medicine (NLM) at the National Institutes of Health (NIH), US Department of Health and Human Services.