Table 2 Clinical trials of FMT modulate the efficacy and AEs of ICI www.clinicaltrials.gov
From: Gut microbiota influence immunotherapy responses: mechanisms and therapeutic strategies
NCT number | Cancer types | n | Intervention | Outcome(s) | Stage | References |
|---|---|---|---|---|---|---|
Modulation of the gut microbiome to improve ICI efficacy | ||||||
NCT04056026 | Mesothelioma | 1 | FMT + Pembrolizumab | PFS | Phase 1 | – |
NCT04521075 | Melanoma, NSCLC | 50 | FMT + Nivolumab | FMT-related AEs, ORR | Phase 1–2 | – |
NCT04130763 | Gastrointestinal | 10 | FMT + Anti-PD-1 | FMT-related AEs, ORR | Phase 1 | – |
NCT04116775 | Prostate | 32 | FMT + Enzalutamide + Pembrolizumab | Anticancer effect | Phase 2 | – |
NCT04729322 | dMMR CRC | 15 | FMT + Pembrolizumab–Nivolumab | ORR | Phase 1 | – |
NCT04577729 | Melanoma | 60 | Allogenic FMT + ICI versus Autologous FMT + ICI | PFS | NA | – |
NCT04758507 | RCC | 50 | Donor FMT + ICI versus Placebo FMT + ICI | PFS | Phase 1–2 | – |
NCT04924374 | NSCLC | 20 | Anti-PD-1 + FMT versus Anti-PD-1 | Treatment safety and responses | NA | – |
NCT04988841 | Melanoma | 60 | MaaT013 + Ipilimumab + Nivolumab versus placebo + Ipilimumab + Nivolumab | AE, ORR | Phase 2 | – |
NCT03772899 | Melanoma | 20 | FMT + Pembrolizumab/Nivolumab | Safety, ORR | Phase 1 | – |
NCT03341143 | Melanoma | 20 | FMT + Pembrolizumab | ORR | Phase 2 | [14] |
NCT03353402 | Melanoma | 40 | FMT + ICI | FMT-related AEs, | Phase 1 | [15] |
Modulation of the gut microbiome to prevent ICI-related AEs | ||||||
NCT04038619 | RCC | 40 | Loperamide + FMT + ICI | FMT-related AEs, ICI-related diarrhea/colitis | Phase 1 | – |
NCT04163289 | Renal cancer | 20 | FMT + Nivolumab/Ipilimumab | Immune-related colitis | Phase 1 | – |
NCT03819296 | Solid tumors | 800 | FMT + Infliximab/Vedolizumab | FMT-related AEs, ICI-related colitis | Phase 1–2 | – |
NCT04883762 | Solid tumors | 10 | FMT + ICI | FMT-related AEs, ICI-related diarrhea | Phase 1 | – |