Table 2 FDA-approved trials of microbial-related immunotherapy
From: Intestinal microbiota: a new force in cancer immunotherapy
NCT Number | Title | Status | Conditions | Interventions | Phases |
|---|---|---|---|---|---|
NCT02960282 | Gut Microbiome in Fecal Samples From Patients With Metastatic Cancer Undergoing Chemotherapy or Immunotherapy | Recruiting | Metastatic Carcinoma Stage IV/IVA/IVB Colorectal Cancer | Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis | Â |
NCT03341143 | Fecal Microbiota Transplant (FMT) in Melanoma Patients | Recruiting | Melanoma | FMT with Pembrolizumab | Phase 2 |
NCT03353402 | Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy | Recruiting | Melanoma Stage IV Unresectable Stage III Melanoma | FMT | Phase 1 |
NCT03370861 | How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes | Recruiting | Skin Cancer|Melanoma Merkel Cell Carcinoma Squamous Cell Carcinoma of the Skin Basal Cell Carcinoma | Immunotherapy | Â |
NCT03383107 | Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome | Recruiting | Breast Cancer|Prostate Cancer | Â | Â |
NCT03557749 | Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies | Recruiting | Immune and Microbial Reconstitution Recurrent Malignant Cell Therapy/Immunotherapy Patients | Diagnostic Test: Blood Sample/Stool Sample Gastrointestinal biopsy × 2–4/ Apheresis Product/Final cellular product |  |
NCT03595683 | Pembrolizumab and EDP1503 in Advanced Melanoma | Recruiting | Melanoma (Skin)|Melanoma | Pembrolizumab Biological: EDP1503 | Phase 2 |
NCT03643289 | Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics | Recruiting | Melanoma (Skin) | Â | Â |
NCT03686202 | Feasibility Study of Microbial Ecosystem Therapeutics (MET-4) to Evaluate Effects of Fecal Microbiome in Patients on Immunotherapy | Recruiting | All Solid Tumors | Biological: MET-4 | Early Phase 1 |
NCT03772899 | Fecal Microbial Transplantation in Combination With Immunotherapy in Melanoma Patients (MIMic) | Recruiting | Melanoma | FMT | Phase 1 |
NCT03797170 | Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma | Recruiting | Diffuse Large B Cell Lymphoma | Gut microbiota samples | Â |
NCT03817125 | Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention | Recruiting | Metastatic Melanoma | Placebo for antibiotic Vancomycin pretreatment Nivolumab/SER-401/SER-401 | Phase 1 |
NCT03891979 | Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma | Not yet recruiting | Pancreatic Cancer | Antibiotics and Pembrolizumab | Phase 4 |