Table 4 Clinical studies registered in Clinicaltrials.gov using fecal microbiota transplant in hematologic and oncologic patients
From: Intestinal barrier functions in hematologic and oncologic diseases
NCT# | Study | Primary outcome measurements | Number of patients (n) |
|---|---|---|---|
05273255 | An open label feasibility study of fecal microbiota transplantation (FMT) in patients with malignancies not responding to Immune Checkpoint Inhibitor (ICI) therapy | Change in the intestinal microbiome community | 30 |
04951583 | Phase II trial of fecal microbial transplantation in patients with advanced non-small cell lung cancer and melanoma treated with Immune Checkpoint Inhibitors | Objective response rate in the NSCLC cohort | 70 |
04577729 | Inducing remission in melanoma patients with checkpoint inhibitor therapy using fecal microbiota transplantation | Progression free survival | 60 |
05251389 | Conversion of unresponsiveness to immunotherapy by fecal microbiota transplantation in patients with metastatic melanoma: A randomized Phase Ib/IIa trial | Efficacy, defined as clinical benefit (stable disease, partial response, complete response) | 24 |
04711967 | Prospective study of fecal microbiota transplantation for acute intestinal GVHD after allogeneic hematopoietic stem cell transplantation | 1) Change in times of stool; 2) Change in volume of stool | 20 |
04269850 | Pilot study of fecal microbiota transplantation in combination with ruxolitinib and steroids for severe acute intestinal graft-versus-host-disease after allogeneic hematopoietic stem cell transplantation | Overall survival | 20 |
04935684 | Faecal microbiota transplantation for prevention of graft-versus-host disease after allogeneic stem cell transplantation for haematological malignancies | Graft-versus-host disease and Relapse-Free Survival rate | 150 |
04521075 | A Phase Ib trial to evaluate the safety and efficacy of fecal microbial transplantation (FMT) in combination with nivolumab in subjects with metastatic or inoperable melanoma, microsatellite instability-high (MSI-H) or mismatch-repair deficient (dMMR) cancer, or non-small cell lung cancer (NSCLC) | 1) Incidence of FMT-related Adverse Events; 2) Overall Response Rate | 42 |
05286294 | MITRIC: Microbiota transplant to cancer patients who have failed immunotherapy using faeces from clinical responders | 1) Safety evaluation of fecal microbiota transplant; 2) Tumor response evaluation | 20 |
05279677 | Phase II, single-arm study of FMT combined with immune checkpoint inhibitor and TKI in the treatment of colorectal cancer patients with advanced stage | Overall response rate | 30 |
04116775 | A Phase II single arm study of fecal microbiota transplant (FMT) in men with metastatic castration resistant prostate cancer whose cancer has not responded to enzalutamide + pembrolizumab | Anticancer effect of fecal microbiota transplant from responders to pembrolizumab to non-responders | 32 |
04163289 | Preventing immune-related adverse events in renal cell carcinoma patients treated with combination immunotherapy using fecal microbiota transplantation | Occurrence of immune-related colitis associated with ipilimumab/nivolumab treatment | 20 |
04758507 | Targeting gut microbiota to improve efficacy of immune checkpoint inhibitors in patients with advanced renal cell carcinoma | Number of participants who will be free from tumor progression | 50 |
04264975 | Utilization of microbiome as biomarkers and therapeutics in immuno-oncology | Overall response rate | 60 |
03819296 | Role of microbiome in the realm of immune-checkpoint inhibitor induced GI complications in cancer population | 1) Difference in stool microbiome pattern; 2) Incidence of adverse events of fecal microbiota transplantation | 800 |
04729322 | Pilot trial of fecal microbiota transplantation and re-introduction of anti-PD-1 therapy in dMMR colorectal adenocarcinoma anti-PD-1 non-responders | Objective response rate | 15 |
03819803 | Fecal microbiota transplantation in patients with acute gastrointestinal graft-versus-host-disease after allogeneic stem cell transplantation | Gastrointestinal GVHD remission | 15 |
04745221 | Efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation: A multicenter, open, randomized controlled clinical study | Acute graft-versus-host disease | 100 |
04988841 | Prospective randomized clinical trial assessing the tolerance and clinical benefit of fecal transplantation in patients with melanoma treated with CTLA-4 and PD1 inhibitors | Safety of a 23 week treatment with MaaT013, combined with ipilimumab + nivolumab in patients with melanoma naïve to Ipilimumab and anti-PD1 | 60 |
04975217 | Pilot study using fecal microbial transplants in patients with pancreatic cancer | Incidence of adverse events | 10 |
04924374 | Microbiota transplant in advanced lung cancer treated with immunotherapy | Measures of safety | 20 |
04769895 | Evaluation of the efficacy of MaaT013 as salvage therapy in acute GVHD patients with gastrointestinal involvement, refractory to ruxolitinib; a Multi-center Open-label Phase III trial | Overall response rate of gastrointestinal acute GVHD | 75 |