Clinical trials to evaluate the efficacy of FMT in ICI response and irAE risk (top) or ICI colitis treatment (bottom)
| ClinicalTrials.gov identifier . | Study title . | Condition or Disease . | Intervention/Treatment (non-ICI) . | Phase and status . |
|---|---|---|---|---|
| Clinical trials for cancer | ||||
| NCT05008861 | Gut microbiota reconstruction for NSCLC immunotherapy | Non-small cell lung cancer | FMT Platinum-based chemotherapy | Phase 1 Not yet recruiting |
| NCT04729322 | Fecal microbiota transplant and re-introduction of anti-PD-1 therapy (Pembrolizumab or Nivolumab) for the treatment of metastatic colorectal cancer in anti-PD-1 non-responders | Colorectal cancer Small intestinal adenocarcinoma | FMT Metronidazole Neomycin Vancomycin | Early Phase 1 Recruiting |
| NCT04163289 | Preventing toxicity in renal cancer patients treated with immunotherapy using fecal microbiota transplantation (PERFORM) | Renal cell carcinoma | FMT | Phase 1 Recruiting |
| NCT04130763 | Fecal microbiota transplant (FMT) capsule for improving the efficacy of anti-PD-1 | Gastrointestinal system cancer | FMT | Phase 1 Unknown |
| NCT05502913 | Fecal microbiota transplantation with immune checkpoint inhibitors in lung cancer | Metastatic lung cancer | FMT Antibiotics | Phase 2 Not yet recruiting |
| NCT05279677 | FMT combined with immune checkpoint inhibitor and TKI in the treatment of CRC patients with advanced cancer | Colorectal neoplasms, malignant | FMT | Phase 2 Recruiting |
| NCT05251389 | FMT to convert response to immunotherapy | Melanoma Stage III and IV | FMT | Phase 1 Phase 2 Recruiting |
| NCT04758507 | Fecal microbiota transplantation to improve efficacy of immune checkpoint inhibitors in renal cell carcinoma (TACITO) | Renal cell carcinoma | FMT | Phase 1 Phase 2 Recruiting |
| NCT05273255 | Fecal microbiota transplantation in patients with malignancies not responding to immune checkpoint inhibitor therapy | Any cancer | FMT | Not applicable Recruiting |
| NCT04577729 | The IRMI-FMT trial | Malignant melanoma, stage III or IV | FMT, allogeneic FMT, autologous | Not applicable Recruiting |
| Clinical trials for ICI colitis | ||||
| NCT04038619 | Fecal microbiota transplantation in treating immune-checkpoint inhibitor induced-diarrhea or colitis in genitourinary cancer patients | Malignant genitourinary system neoplasms ICI colitis Diarrhea | FMT Loperamide | Phase 1 Recruiting |
| NCT04883762 | Stool transplant to control treatment-related diarrhea | FMT ICI colitis | FMT | Phase 1 Recruiting |
| NCT03819296 | Role of gut microbiome and fecal transplant on medication-induced GI complications in patients with cancer | Solid tumors ICI colitis | FMT Infliximab Prednisone Vedolizumab | Phase 1 Phase 2 Recruiting |
| ClinicalTrials.gov identifier . | Study title . | Condition or Disease . | Intervention/Treatment (non-ICI) . | Phase and status . |
|---|---|---|---|---|
| Clinical trials for cancer | ||||
| NCT05008861 | Gut microbiota reconstruction for NSCLC immunotherapy | Non-small cell lung cancer | FMT Platinum-based chemotherapy | Phase 1 Not yet recruiting |
| NCT04729322 | Fecal microbiota transplant and re-introduction of anti-PD-1 therapy (Pembrolizumab or Nivolumab) for the treatment of metastatic colorectal cancer in anti-PD-1 non-responders | Colorectal cancer Small intestinal adenocarcinoma | FMT Metronidazole Neomycin Vancomycin | Early Phase 1 Recruiting |
| NCT04163289 | Preventing toxicity in renal cancer patients treated with immunotherapy using fecal microbiota transplantation (PERFORM) | Renal cell carcinoma | FMT | Phase 1 Recruiting |
| NCT04130763 | Fecal microbiota transplant (FMT) capsule for improving the efficacy of anti-PD-1 | Gastrointestinal system cancer | FMT | Phase 1 Unknown |
| NCT05502913 | Fecal microbiota transplantation with immune checkpoint inhibitors in lung cancer | Metastatic lung cancer | FMT Antibiotics | Phase 2 Not yet recruiting |
| NCT05279677 | FMT combined with immune checkpoint inhibitor and TKI in the treatment of CRC patients with advanced cancer | Colorectal neoplasms, malignant | FMT | Phase 2 Recruiting |
| NCT05251389 | FMT to convert response to immunotherapy | Melanoma Stage III and IV | FMT | Phase 1 Phase 2 Recruiting |
| NCT04758507 | Fecal microbiota transplantation to improve efficacy of immune checkpoint inhibitors in renal cell carcinoma (TACITO) | Renal cell carcinoma | FMT | Phase 1 Phase 2 Recruiting |
| NCT05273255 | Fecal microbiota transplantation in patients with malignancies not responding to immune checkpoint inhibitor therapy | Any cancer | FMT | Not applicable Recruiting |
| NCT04577729 | The IRMI-FMT trial | Malignant melanoma, stage III or IV | FMT, allogeneic FMT, autologous | Not applicable Recruiting |
| Clinical trials for ICI colitis | ||||
| NCT04038619 | Fecal microbiota transplantation in treating immune-checkpoint inhibitor induced-diarrhea or colitis in genitourinary cancer patients | Malignant genitourinary system neoplasms ICI colitis Diarrhea | FMT Loperamide | Phase 1 Recruiting |
| NCT04883762 | Stool transplant to control treatment-related diarrhea | FMT ICI colitis | FMT | Phase 1 Recruiting |
| NCT03819296 | Role of gut microbiome and fecal transplant on medication-induced GI complications in patients with cancer | Solid tumors ICI colitis | FMT Infliximab Prednisone Vedolizumab | Phase 1 Phase 2 Recruiting |