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. 2020 Jun 3;9(1):1774298. doi: 10.1080/2162402X.2020.1774298

Table 1.

Clinical trials employing microbial products for cancer therapy. AFMT: autologous fecal microbial transplantation; GvHD: graft-versus-host disease; ICBs: immune checkpoint blockers; irAE: immune-related adverse event; MDRB: multi-drug resistant bacteria; ORR: objective response rate; OS: overall survival; PFS: progression-free Survival; PSA: prostate-specific antigen; RRR: radiographic response rate; TKI: tyrosine kinase inhibitor.

Microbial intervention Sponsor NCT Therapeutic intervention Cancer type Phase Primary Endpoint Secondary Endpoint
Clinical Trials investigating the capacity of the gut microbiota to boost ICBs efficacy
FMT Zarour, Hassane NCT03341143 Pembrolizumab Melanoma II ORR Immune biomarkers
FMT Sheba Medical Center NCT03353402 PD-1 inhibitor Melanoma I Safety, engraftment ORR, immune biomarkers
FMT Lawson Health Research Institute NCT03772899 Pembrolizumab/Nivolumab Melanoma I Safety ORR, microbiome, metabolome, blood biomarkers
FMT Julie Graff NCT04116775 Pembrolizumab Prostate II PSA RRR, PFS, OS
FMT Peking University NCT04130763 PD-1 inhibitor Gastrointestinal System Cancer I ORR, Safety Immune biomarkers
FMT Asan Medical Center NCT04264975 Immunotherapy Solid carcinoma Not Applicable ORR  
FMT ProgenaBiome NCT04056026 Keytruda Mesothelioma I PFS  
Consortia University Health Network, Toronto NCT03686202 PD-1/PD-L1 inhibitor Solid tumors I Safety, engraftment ORR, PFS, microbiome, immune biomarkers
Single strain 4D pharma plc NCT03637803 Pembrolizumab Solid tumors I/II Safety, Tolerability, Clinical befinit Immune biomarkers
Single strain University of Chicago NCT03595683 Pembrolizumab Melanoma II Response rate, adverse events PFS
Consortia Parker Institute for Cancer Immunotherapy NCT03817125 Nivolumab Melanoma I Adverse events Engraftment, ORR, PFS, OS, immune biomarkers
Consortia Vedanta Biosciences, Inc. NCT04208958 Nivolumab Selected types of advanced or metastatic cancer I/II Safety, Tolerability, Clinical befinit Engraftment, PFS, OS, duration of response
Single strain Evelo Biosciences, Inc NCT03775850 Pembrolizumab Selected types of advanced or metastatic cancer I/II Safety, Tolerability, ORR PFS, OS
Clinical Trials investigating the capacity of the gut microbiota to modulate the tumor microenvironment before tumor resection
FMT Mayo Clinic NCT04139993 X Operable Stage I–III Breast Cancer I Safety Engraftment, immune biomarkers
Single strain Imperial College London NCT03934827 X Operable solid tumors I Safety, tolerability OS, immune biomarkers
Single strain 4D pharma plc NCT04193904 Radiation Pancreatic I Safety Immune biomarkers, OS, PFS
Clinical Trials investigating the capacity of the gut microbiota to mitigate anticancer treatments-related colitis
FMT M.D. Anderson Cancer Center NCT04038619 ICBs Genitourinary Cancer Patients I Safety, tolerability, efficacy Recurrence rate
FMT Catholic University of the Sacred Heart NCT04040712 TKI Renal Cell carcinoma Not Applicable Rate of patients with diarrhea Rate of patients who need to stop/reduce TKI
FMT Lawson Health Research Institute NCT04163289 ICBs Renal Cell carcinoma I Occurence of immune-related colitis irAE, ORR
FMT M.D. Anderson Cancer Center NCT03819296 ICBs Melanoma I Incidence of adverse events, Toxicity  
Clinical Trials investigating the capacity of the gut microbiota to circumvent corticosteroid-resistant acute GvHD in hematologic malignancies
FMT Shanghai General Hospital, NCT03812705 X Hematopoietic and Lymphoid Cell Neoplasm II Response Rate Time to response, duration of response
Shanghai Jiao Tong University School of Medicine
FMT Maat Pharma NCT02928523 X Acute Myeloid Leukemia I/II AFMT efficacy, eradication of MDRB  
FMT Masonic Cancer Center, University of Minnesota NCT03678493 X Acute Myeloid Leukemia II Incidence of infections Engraftment, incidence of GvHD
FMT MaaT Pharma NCT03359980 X Steroid Refractory, Gastrointestinal, Acute GvHD II Efficacy Safety, MDRB, incidence of GvHD
FMT Massachusetts General Hospital NCT02733744 X Bone Marrow Transplantation I Feasability OS, PFS, incidence of GvHD