Table 1.
Clinical trials currently testing the activity and safety of microbiome therapeutic agents alone or in combination with an immune checkpoint inhibitor in patients with cancer.
| Organization | Product | Indication | Study | Dose | Cohorts |
|---|---|---|---|---|---|
| Parker Institute for Cancer Immunotherapy |
SER-401 (donor derived, enriched in Ruminococcaceae) | Metastatic melanoma | Phase 1b (NCT03817125) | Initial daily loading dose (one capsule) for 7 days, followed by maintenance dose (one capsule) + nivolumab for 8 weeks | N = 30 |
| 4D Pharma |
MRx0518 (Enterococcus gallinarum) |
Solid tumors, PD-1 relapsed Solid tumors |
Phase 1/2 (NCT03637803) Phase 1/2 (NCT03934827a) |
1 capsule BID + pembrolizumab 1 capsule BID for 2–4 weeks |
N = 132 Open label Part A: open label (N = 20) Part B: 4:1 versus placebo (N = 100) |
| Evelo Biosciences |
EDP1503 (Bifidobacterium spp.) |
Solid tumors, PD-1 relapsed Advanced melanoma |
Phase 1/2 (NCT03775850) Phase 2 (NCT03595683b) |
Two capsules BID (3 × 1011 CFU) + pembrolizumab Two capsules BID (3 × 1011 CFU) + pembrolizumab |
N = 120 Open-label cohorts based on indication N = 70 Two open-label cohorts based on PD-1 response |
| Nubiyota | MET-4 (defined consortium) | Solid tumors | Phase 1 (NCT03686202) | Initial daily loading dose of 5 g (10 capsules) for 2 days, followed by maintenance doses of 1.5 g (three capsules) + checkpoint inhibitor |
N = 65 Three groups |
| Vedanta Biosciences | VE800 (11-strain defined consortium) | Advanced metastatic cancer | Phase 1/2 (NCT04208958c) | Daily dosing + nivolumab every 4 weeks | N = 111 |
BID, twice daily; CFU, colony-forming units.
a
Sponsored by Imperial College London.
b
Sponsored by the University of Chicago.
c
In collaboration with Bristol Myers Squibb.