Table 2. Clinical trials evaluating microbial role/intervention as immunotherapy modulator in cancer.
(based on ClinicalTrials.gov, website maintained by the National Library of Medicine, at the US National Institutes of Health (NIH)
| ClinicalTrials.gov Identifier | Name of the study | Conditions | Comments | Status |
|---|---|---|---|---|
| NCT02960282 | Gut Microbiome in Fecal Samples from Patients with Metastatic Cancer Undergoing Chemotherapy or Immunotherapy | Colorectal Cancer (stage 4) | Observational study; Biospecimen Collection; Laboratory Biomarker Analysis | Recruiting |
| NCT03643289 | Predicting Response to Immunotherapy for Melanoma with Gut Microbiome & Metabolomics | Melanoma (stage 4) | Observational study; Assess the gut microbiome diversity with metagenome sequencing before and after immunotherapy | Recruiting |
| NCT03688347 | Microbiome in Lung Cancer and other Malignancies | Lung cancer, other cancers | Observational study; Assess the nasal, oral and fecal microbiome, and correlate the data with treatment response and toxicities of immunotherapy | Recruiting |
| NCT03686202 | Feasibility Study of Microbial Ecosystem Therapeutics (MET-4) to Evaluate Effects of Fecal Microbiome in Patients on Immunotherapy | Solid tumors | Interventional (Phase 1); Assess the safety, tolerability and engraftment of Microbial Ecosystem Therapeutics (MET-4) strains when given in combination with immunotherapy | Recruiting |
| NCT02592967 | Safety & Immunogenicity of JNJ-64041757, Live-attenuated Double-deleted Listeria Immunotherapy, in Subjects with Non Small Cell Lung Cancer | Non-small cell lung cancer (NSCLC) (stages 3B and 4) | Interventional (Phase 1); Assess the JNJ-64041757, a live attenuated double deleted (LADD) Listeria monocytogenes as single immunotherapy | Active |
| NCT02625857 | Safety & Immunogenicity of JNJ-64041809, a Live Attenuated Double-deleted Listeria Immunotherapy, in Participants with Metastatic Castration-resistant Prostate Cancer | Prostate cancer, castration-resistant | Interventional (Phase 1); Assess the JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes as single immunotherapy | Completed |
| NCT02843425 | The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial | Colorectal cancer Prevention | Interventional; Assess the fiber supplementation -induced shift in bacterial populations, through the addition of a half cup of beans/day into the normal diets of cancer patients | Recruiting |