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This investigational combination therapy is being evaluated by the M.D. Anderson Cancer Center for the treatment of metastatic colorectal adenocarcinoma and small intestinal adenocarcinoma. The regimen involves the use of Fecal Microbiota Transplantation (FMT) in conjunction with the re-introduction of anti-PD-1 immune checkpoint inhibitors, specifically pembrolizumab or nivolumab. The approach is targeted at patients with deficient mismatch repair (dMMR) tumors who have previously failed or progressed on anti-PD-1 therapy. FMT, which contains healthy bacteria and viruses from donor stool, is used to modulate the gut microbiome, aiming to restore the immune system's sensitivity to checkpoint inhibition and overcome therapeutic resistance. The therapy is administered via colonoscopic transplant or oral capsules, following a gut decontamination protocol using antibiotics such as metronidazole, neomycin, and vancomycin.
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