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 |