Non-randomized clinical trials
NCT03772899
revealed
- that In patients with melanoma undergoing therapy, the use of FMT followed by anti-PD-1 treatment is considered safe. This approach may enhance anti-tumor responses, which can also be replicated in tumor mouse models (1)
- that in the initial treatment phase, fecal microbiota transplantation (FMT) from healthy donors is considered safe and merits additional research when used alongside immune checkpoint inhibitors (2).
- This combination also showed an improvement in overall response rate (ORR), mPFS, and median overall survival (mOS) compared to results from randomized trials. It is important to note that the sample size was small, and the results are considered hypothesis-generating (3)
NCT04521075
No published results were found as of May 2026
References
(1) Miller et al. 2022 J Clin Oncol 40: suppl 16 abstr 9533
(2) Routy et al. 2023 Nat Med 29: 2121-2132
(3) Hadi et al. 2025 Journal for ImmunoTherapy of Cancer 13: e012659
see also:
Fecal Microbiota Transplantation (FMT) + Immune Checkpoint Inhibitors (ICIs) & Melanoma (cutaneous)
Gut microbiota & Immune Checkpoint Inhibitors (ICIs)
Melanoma (cutaneous) & Drugs/Treatments
