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Table 3 Ongoing select clinical studies investigating the effect of gut microbiota on anticancer therapies

From: The gut microbiome and response to immune checkpoint inhibitors: preclinical and clinical strategies

Study Tumor, setting Interventions Primary endpoint(s) NCT
Observational, n = 49 TNBC, newly diagnosed Neoadjuvant chemotherapy with collection with pre- and post-therapy stool and PB samples pCR rate as associated with composition of intestinal microbiota and subsequent short-term alterations in composition NCT03586297
Observational, n = 80 Metastatic CRC, first-line; metastatic carcinoma, first-line anti-PD-1/PD-L1 therapy FOLFOX or FOLFIRI or anti-PD-1/PD-L1 therapy with collection of pre-therapy and interval stool samples Tumor response correlated with presence and amounts of species NCT02960282
Observational, n = 120 AML, newly diagnosed or undergoing HSCT Serial stool samples analyzed by next-generation sequencing Association between changes in the intestinal microbiota and the incidence of gastrointestinal GVHD NCT03148197
Case–control, n = 200 Glioblastoma multiforme, first-line Concurrent chemoradiation (temozolomide) or radiation therapy or healthy control and collection of pre- and post-surgery stool samples Pre-operative gut microbiome composition, perturbation of gut microbiota by temozolomide, and correlation of gut microbiota and prognosis NCT03631823
Phase I, n = 40 Advanced melanoma, treatment refractory FMT from responders of immunotherapy Safety and comparison of gut microbiome composition pre- and post-FMT NCT03353402
Phase I/II, n = 20 AML or high-risk MDS, first-line Induction therapy + autologous FMT Efficacy in dysbiosis correction by measure of microbiota diversity and eradication of MDRB NCT02928523
Phase II, n = 20 Advanced melanoma, treatment refractory FMT + pembrolizumab ORR NCT03341143
Phase II, n = 144 Any hematologic malignancy undergoing HSCT Piperacillin–tazobactam or cefepime Fold-change in Clostridiales abundance NCT03078010
  1. NCT ClinicalTrials.gov identifier, TNBC triple-negative breast cancer, PB peripheral blood, CRC colorectal cancer, PD-L1 programmed death ligand 1, PD-1 programmed cell death protein 1, FOLFOX 5-fluorouracil, leucovorin, and oxaliplatin, FOLFIRI 5-fluorouracil, leucovorin, and irinotecan, AML acute myeloid leukemia, HSCT hematopoietic stem cell transplantation, GVHD graft-versus-host disease, FMT fecal microbiota transplantation, MDS myelodysplastic syndrome, MDRB multidrug resistant bacteria, ORR overall response rate