Ongoing clinical trials using MCIs (FMT, probiotics, or dietary interventions) in combination with immunotherapy
NCT number (Ref.) . | MCI . | Immunotherapy treatment . | Cancer type . | Enrolment (estimated) . | Phase . | Country . | Start . | Status . |
|---|---|---|---|---|---|---|---|---|
| FMT | ||||||||
| NCT04116775 | FMT | Pembrolizumab | Metastatic castration–resistant Prostate cancer | 32 | 2 | USA | 10-30-2019 | Unknown |
| NCT04130763 (Peng et al., 2023) | FMT capsules | Anti-PD-1 | GI cancer | 10 | 1 | China | 12-05-2019 | Completed |
| NCT04163289 (Fernandes et al., 2022) | FMT | Nivolumab + ipilimumab | RCC | 20 | 1 | Canada | 01-23-2020 | Active, not recruiting |
| NCT04521075 | FMT capsules | Nivolumab + ipilimumab | Melanoma, NSCLC | 42 | 1–2 | Israel | 11-01-2020 | Unknown |
| NCT04758507 (Ciccarese et al., 2024; Porcari et al., 2022) | FMT from donors who are responding to ICB | Standard of care | RCC | 50 | 1–2 | Italy | 02-18-2021 | Active, not recruiting |
| NCT03819296 (Wang et al., 2023) | FMT from healthy volunteers | ICB | Melanoma, genitourinary, MSN, lung | 800 | 1–2 | USA | 02-21-2021 | Recruiting |
| NCT04729322 | FMT from ICB-responding patients | Pembrolizumab or nivolumab | Metastatic dMMR CRC | 15 | 2 | USA | 02-22-2021 | Active, not recruiting |
| NCT04924374 | FMT capsules from three donors | Anti-PD-1/PD-L1 | NSCLC | 25 | N/A | Spain | 04-23-2021 | Completed |
| NCT04577729 | Allogenic or Autologous FMT | ICB | Melanoma | 5 | N/A | Austria | 05-21-2021 | Terminated |
| NCT05008861 | Capsulized FMT | Anti-PD-1/PD-L1 | NSCLC | 20 | 1 | China | 09-01-2021 | Unknown |
| NCT04056026 | FMT infusion from a healthy family d onor via colonoscopy | Pembrolizumab | Metastatic mesothelioma | 1 | 1 | USA | 09-18-2021 | Completed |
| NCT04951583 (Elkrief et al., 2024a) | FMT | Pembrolizumab Ipilimumab + nivolumab | Metastatic melanoma, uveal melanoma, NSCLC | 45 | 2 | Canada | 11-16-2021 | Active, not recruiting |
| NCT04988841 | FMT from pooled donors (MaaT013) | Ipilimumab + nivolumab | Melanoma | 60 | 2 | France | 01-20-2022 | Recruiting |
| NCT05273255 | FMT from patients responding to ICB therapy, via colonoscopy | ICB | Refractory malignancy | 18 | N/A | Switzerland | 03-14-2022 | Completed |
| NCT05286294 (Ullern et al., 2024) | FMT from ICB-responding patients | ICB | Melanoma, NSCLC, CSCC, HNSCC, RCC, MSI+ solid cancer | 20 | 2 | Norway | 06-28-2022 | Recruiting |
| NCT05279677 | FMT | Sintilimab + fruquintinib | CRC | 30 | 2 | China | 08-12-2022 | Unknown |
| NCT05251389 (Borgers et al., 2022) | FMT from an ICB-responding or an ICB-non-responding donor | Anti-PD-1 | Metastatic melanoma | 24 | 1–2 | Netherlands | 08-31-2022 | Recruiting |
| NCT05533983 | FMT from a single donor, responder patients | Nivolumab | Advanced solid cancers | 50 | N/A | Republic of Korea | 09-10-2022 | Not yet recruiting |
| NCT05750030 | FMT from HCC responder patients | Atezolizumab + bevacizumab | Refractory HCC | 12 | 2 | Austria | 05-16-2023 | Recruiting |
| NCT05502913 (Massalha et al., 2023) | FMT from complete responder patients | ICB ± CTX | Lung cancer | 80 | 2 | Israel | 09-01-2023 | Recruiting |
| NCT05690048 | FMT capsules | Atezolizumab + bevacizumab | HCC | 48 | 2 | Germany | 01-01-2024 | Not yet recruiting |
| NCT06346093 | FMT capsules | Anti-PD-L1 + CTX | Advanced gastric cancer | 66 | N/A | China | 04-02-2024 | Recruiting |
| NCT06405113 | FMT | SOX + sintilimab | Advanced gastric cancer | 198 | 2 | China | 06-01-2024 | Not yet recruiting |
| NCT06403111 | FMT | Tislelizumab + CTX | NSCLC | 62 | 2 | China | 06-01-2024 | Recruiting |
| NCT06486220 | FMT (oral healthy intestinal bacterium freeze-dried powder capsules) | Anti-PD-1 + CTX | Metastatic NPC | 96 | 3 | China | 07-01-2024 | Not yet recruiting |
| NCT05669846 (Burns et al., 2024) | FMT from durable-remission patients | Pembrolizumab | NSCLC | 26 | 2 | USA | 12-27-2024 | Recruiting |
| NCT06643533 | FMT capsules | Sintilimab + lenvatinib + CTX | HCC | 15 | N/A | China | 01-01-2025 | Not yet recruiting |
| NCT06030037 (Wang et al., 2024) | FMT from responder patients | Pembrolizumab + lenvatinib | Melanoma | 56 | 2 | USA | 01-31-2025 | Not yet recruiting |
| NCT06801665 | FMT | QL1706 + bevacizumab + CTX | MSS+ CRC | 30 | 2 | China | 02-01-2025 | Not yet recruiting |
| NCT06623461 | LND101 FMT | ICB | Advanced melanoma | 128 | 2 | Canada | 02-28-2025 | Not yet recruiting |
| Probiotics | ||||||||
| NCT03595683 | EDP1503: Bifidobacterium spp. | Pembrolizumab | Melanoma | 8 | 2 | USA | 10-02-2018 | Active, not recruiting |
| NCT04699721 | Bifidobacterium trifidum live powder (BiFico, SINE) | Nivolumab + CTX | NSCLC | 60 | 2 | China | 07-01-2020 | Active, not recruiting |
| NCT05620004 | Bifidobacterium bifidum | Carrilizumab + apatinib mesylate | HCC | 30 | 1-2 | China | 11-01-2021 | Unknown |
| NCT05094167 | Lactobacillus Bifidobacterium V9(Kex02) | Carrilizumab + CTX | NSCLC | 46 | N/A | China | 10-19-2021 | Unknown |
| NCT05032014 | Lactobacillus rhamnosus Probio-M9 | Anti-PD-1 | Liver cancer | 46 | N/A | China | 11-19-2021 | Unknown |
| NCT05220124 | Live combined (Bifidobacterium, Lactobacillus, and Enterococcus capsules) | ICB | UBC | 190 | 4 | China | 01-05-2022 | Unknown |
| NCT05354102 (Perets et al., 2024) | BMC128 | Nivolumab | ccRCC/cutaneous melanoma/NSCLC | 11 | 1 | Israel | 05-01-2022 | Active, not recruiting |
| NCT05865730 | Oncobax-AK: Akkermansia massiliensis | ICB | NSCLC/RCC | 122 | 2 | France | 10-01-2022 | Recruiting |
| NCT06399419 | CBM588: Clostridium butyricum MIYAIRI 588 | Nivolumab or ipilimumab | RCC | 28 | 1 | USA | 06-19-2024 | Recruiting |
| NCT06448572 | EXL01: Faecalibacterium Prausnitzii | Nivolumab | Advanced/metastatic NSCLC | 21 | 1–2 | France | 07-16-2024 | Recruiting |
| NCT06508034 | VSL#3 450B (live freeze-dried lactic acid bacteria probiotic) | Ipilimumab +/− anti-PD-1 or PD-L1 Anti-PD-1/PD-L1 +/− CTX | Solid malignancy | 30 | N/A | USA | 07-31-2024 | Recruiting |
| NCT06428422 | Bifidobacterium animalis subsp. lactis Bl-04 | Nivolumab | NSCLC | 100 | N/A | Turkey | 08-12-2024 | Recruiting |
| NCT06551272 | EXL01: Faecalibacterium Prausnitzii | Atezolizumab + bevacizumab | HCC | 34 | 2 | France | 12-01-2024 | Not yet recruiting |
| NCT06768931 | Biolosion | Anti-PD-1 + CTX | TNBC | 192 | 2 | China | 01-08-2025 | Recruiting |
| NCT06823323 | Lactobacillus johnsonii | CapeOX + pembrolizumab | mCRC | 150 | N/A | China | 03-01-2025 | Not yet recruiting |
| Diet | ||||||||
| NCT04552418 | Dietary intervention | Potato-based dietary starch supplement with dual ICB | HER2+, HR+, and HER2-negative or triple-negative breast cancer | 12 | 1 | USA | 06-02-2021 | Completed |
| NCT05805319 | Dietary intervention | Increased fiber intake concomitant with ICB | NSCLC | 80 | N/A | Canada | 04-27-2023 | Recruiting |
| NCT06438588 | Dietary intervention | Fasting mimicking diet before ICB | Advanced solid cancers | 10 | N/A | USA | 03-06-2024 | Recruiting |
NCT number (Ref.) . | MCI . | Immunotherapy treatment . | Cancer type . | Enrolment (estimated) . | Phase . | Country . | Start . | Status . |
|---|---|---|---|---|---|---|---|---|
| FMT | ||||||||
| NCT04116775 | FMT | Pembrolizumab | Metastatic castration–resistant Prostate cancer | 32 | 2 | USA | 10-30-2019 | Unknown |
| NCT04130763 (Peng et al., 2023) | FMT capsules | Anti-PD-1 | GI cancer | 10 | 1 | China | 12-05-2019 | Completed |
| NCT04163289 (Fernandes et al., 2022) | FMT | Nivolumab + ipilimumab | RCC | 20 | 1 | Canada | 01-23-2020 | Active, not recruiting |
| NCT04521075 | FMT capsules | Nivolumab + ipilimumab | Melanoma, NSCLC | 42 | 1–2 | Israel | 11-01-2020 | Unknown |
| NCT04758507 (Ciccarese et al., 2024; Porcari et al., 2022) | FMT from donors who are responding to ICB | Standard of care | RCC | 50 | 1–2 | Italy | 02-18-2021 | Active, not recruiting |
| NCT03819296 (Wang et al., 2023) | FMT from healthy volunteers | ICB | Melanoma, genitourinary, MSN, lung | 800 | 1–2 | USA | 02-21-2021 | Recruiting |
| NCT04729322 | FMT from ICB-responding patients | Pembrolizumab or nivolumab | Metastatic dMMR CRC | 15 | 2 | USA | 02-22-2021 | Active, not recruiting |
| NCT04924374 | FMT capsules from three donors | Anti-PD-1/PD-L1 | NSCLC | 25 | N/A | Spain | 04-23-2021 | Completed |
| NCT04577729 | Allogenic or Autologous FMT | ICB | Melanoma | 5 | N/A | Austria | 05-21-2021 | Terminated |
| NCT05008861 | Capsulized FMT | Anti-PD-1/PD-L1 | NSCLC | 20 | 1 | China | 09-01-2021 | Unknown |
| NCT04056026 | FMT infusion from a healthy family d onor via colonoscopy | Pembrolizumab | Metastatic mesothelioma | 1 | 1 | USA | 09-18-2021 | Completed |
| NCT04951583 (Elkrief et al., 2024a) | FMT | Pembrolizumab Ipilimumab + nivolumab | Metastatic melanoma, uveal melanoma, NSCLC | 45 | 2 | Canada | 11-16-2021 | Active, not recruiting |
| NCT04988841 | FMT from pooled donors (MaaT013) | Ipilimumab + nivolumab | Melanoma | 60 | 2 | France | 01-20-2022 | Recruiting |
| NCT05273255 | FMT from patients responding to ICB therapy, via colonoscopy | ICB | Refractory malignancy | 18 | N/A | Switzerland | 03-14-2022 | Completed |
| NCT05286294 (Ullern et al., 2024) | FMT from ICB-responding patients | ICB | Melanoma, NSCLC, CSCC, HNSCC, RCC, MSI+ solid cancer | 20 | 2 | Norway | 06-28-2022 | Recruiting |
| NCT05279677 | FMT | Sintilimab + fruquintinib | CRC | 30 | 2 | China | 08-12-2022 | Unknown |
| NCT05251389 (Borgers et al., 2022) | FMT from an ICB-responding or an ICB-non-responding donor | Anti-PD-1 | Metastatic melanoma | 24 | 1–2 | Netherlands | 08-31-2022 | Recruiting |
| NCT05533983 | FMT from a single donor, responder patients | Nivolumab | Advanced solid cancers | 50 | N/A | Republic of Korea | 09-10-2022 | Not yet recruiting |
| NCT05750030 | FMT from HCC responder patients | Atezolizumab + bevacizumab | Refractory HCC | 12 | 2 | Austria | 05-16-2023 | Recruiting |
| NCT05502913 (Massalha et al., 2023) | FMT from complete responder patients | ICB ± CTX | Lung cancer | 80 | 2 | Israel | 09-01-2023 | Recruiting |
| NCT05690048 | FMT capsules | Atezolizumab + bevacizumab | HCC | 48 | 2 | Germany | 01-01-2024 | Not yet recruiting |
| NCT06346093 | FMT capsules | Anti-PD-L1 + CTX | Advanced gastric cancer | 66 | N/A | China | 04-02-2024 | Recruiting |
| NCT06405113 | FMT | SOX + sintilimab | Advanced gastric cancer | 198 | 2 | China | 06-01-2024 | Not yet recruiting |
| NCT06403111 | FMT | Tislelizumab + CTX | NSCLC | 62 | 2 | China | 06-01-2024 | Recruiting |
| NCT06486220 | FMT (oral healthy intestinal bacterium freeze-dried powder capsules) | Anti-PD-1 + CTX | Metastatic NPC | 96 | 3 | China | 07-01-2024 | Not yet recruiting |
| NCT05669846 (Burns et al., 2024) | FMT from durable-remission patients | Pembrolizumab | NSCLC | 26 | 2 | USA | 12-27-2024 | Recruiting |
| NCT06643533 | FMT capsules | Sintilimab + lenvatinib + CTX | HCC | 15 | N/A | China | 01-01-2025 | Not yet recruiting |
| NCT06030037 (Wang et al., 2024) | FMT from responder patients | Pembrolizumab + lenvatinib | Melanoma | 56 | 2 | USA | 01-31-2025 | Not yet recruiting |
| NCT06801665 | FMT | QL1706 + bevacizumab + CTX | MSS+ CRC | 30 | 2 | China | 02-01-2025 | Not yet recruiting |
| NCT06623461 | LND101 FMT | ICB | Advanced melanoma | 128 | 2 | Canada | 02-28-2025 | Not yet recruiting |
| Probiotics | ||||||||
| NCT03595683 | EDP1503: Bifidobacterium spp. | Pembrolizumab | Melanoma | 8 | 2 | USA | 10-02-2018 | Active, not recruiting |
| NCT04699721 | Bifidobacterium trifidum live powder (BiFico, SINE) | Nivolumab + CTX | NSCLC | 60 | 2 | China | 07-01-2020 | Active, not recruiting |
| NCT05620004 | Bifidobacterium bifidum | Carrilizumab + apatinib mesylate | HCC | 30 | 1-2 | China | 11-01-2021 | Unknown |
| NCT05094167 | Lactobacillus Bifidobacterium V9(Kex02) | Carrilizumab + CTX | NSCLC | 46 | N/A | China | 10-19-2021 | Unknown |
| NCT05032014 | Lactobacillus rhamnosus Probio-M9 | Anti-PD-1 | Liver cancer | 46 | N/A | China | 11-19-2021 | Unknown |
| NCT05220124 | Live combined (Bifidobacterium, Lactobacillus, and Enterococcus capsules) | ICB | UBC | 190 | 4 | China | 01-05-2022 | Unknown |
| NCT05354102 (Perets et al., 2024) | BMC128 | Nivolumab | ccRCC/cutaneous melanoma/NSCLC | 11 | 1 | Israel | 05-01-2022 | Active, not recruiting |
| NCT05865730 | Oncobax-AK: Akkermansia massiliensis | ICB | NSCLC/RCC | 122 | 2 | France | 10-01-2022 | Recruiting |
| NCT06399419 | CBM588: Clostridium butyricum MIYAIRI 588 | Nivolumab or ipilimumab | RCC | 28 | 1 | USA | 06-19-2024 | Recruiting |
| NCT06448572 | EXL01: Faecalibacterium Prausnitzii | Nivolumab | Advanced/metastatic NSCLC | 21 | 1–2 | France | 07-16-2024 | Recruiting |
| NCT06508034 | VSL#3 450B (live freeze-dried lactic acid bacteria probiotic) | Ipilimumab +/− anti-PD-1 or PD-L1 Anti-PD-1/PD-L1 +/− CTX | Solid malignancy | 30 | N/A | USA | 07-31-2024 | Recruiting |
| NCT06428422 | Bifidobacterium animalis subsp. lactis Bl-04 | Nivolumab | NSCLC | 100 | N/A | Turkey | 08-12-2024 | Recruiting |
| NCT06551272 | EXL01: Faecalibacterium Prausnitzii | Atezolizumab + bevacizumab | HCC | 34 | 2 | France | 12-01-2024 | Not yet recruiting |
| NCT06768931 | Biolosion | Anti-PD-1 + CTX | TNBC | 192 | 2 | China | 01-08-2025 | Recruiting |
| NCT06823323 | Lactobacillus johnsonii | CapeOX + pembrolizumab | mCRC | 150 | N/A | China | 03-01-2025 | Not yet recruiting |
| Diet | ||||||||
| NCT04552418 | Dietary intervention | Potato-based dietary starch supplement with dual ICB | HER2+, HR+, and HER2-negative or triple-negative breast cancer | 12 | 1 | USA | 06-02-2021 | Completed |
| NCT05805319 | Dietary intervention | Increased fiber intake concomitant with ICB | NSCLC | 80 | N/A | Canada | 04-27-2023 | Recruiting |
| NCT06438588 | Dietary intervention | Fasting mimicking diet before ICB | Advanced solid cancers | 10 | N/A | USA | 03-06-2024 | Recruiting |
ccRCC, clear cell renal cell carcinoma; CRC, colorectal cancer; CSCC, cutaneous squamous cell carcinoma; CTX, chemotherapy; dMMR, mismatch repair deficiency; GI, gastrointestinal; HCC, hepatocellular carcinoma; HER, human epidermal growth factor receptor; HNSCC, head and neck squamous cell carcinoma; HR, hormone receptor; ICB, immune checkpoint blockade; mCRC, metastatic colorectal cancer; MSI-H, high microsatellite instability; MSN, malignant solid neoplasm; N/A, not applicable; NCT, National Clinical Trial; NSCLC, non–small-cell lung cancer; NPC, nasopharyngeal carcinoma; RCC, renal cell carcinoma; TNBC, triple-negative breast cancer; UBC, urothelial bladder carcinoma. All information was collected from https://clinicaltrials.gov.