Table 1.
Trials of FMT in different cancer types
| NCT Number | Patient population | Patients (n) | Intervention | Study Phase | Treatment Setting (PD1 naïve vs Refractory) | Randomized vs Single Arm | FMT Donor (Healthy vs ICB responder) | FMT Donor (Pooled vs single donor) | FMT Modality (Route of Administration) | FMT Frequency | FMT Timing (in relation to PD1) | Primary endpoint | Secondary Endpoints | Study Start Date | Enrollment Status | Sites Enrolling |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03353402 | Anti-PD-1 refractory melanoma | 40 | FMT+ Pembrolizumab/Nivolumab | 1 | Refractory | Single arm | Responder | Pooled | Colonoscopy & Capsule | Not specified | Post | Safety Engraftment | Immune profile change | 11/30/2017 | Recruiting | Sheba Med Center, Tel HaShomer, Israel |
| NCT03341143 | Anti-PD-1 refractory melanoma | 20 | FMT + Pembrolizumab/Nivolumab | 2 | Refractory (non-response at 12 weeks) | Single arm | Responder | Not Specified | Colonoscopy | Single dose | Same day | ORR | Immune profile change Effect on the gut microbiome |
1/10/2018 | Recruiting | University of Pittsburgh, Pennsylvania, USA |
| NCT03772899 | Metastatic melanoma | 20 | FMT + Pembrolizumab/Nivolumab | 1 | Naive | Single arm | Healthy | Single | Capsule | Not specified | 1 week prior to | Safety of combination therapy | ORR Effect on the gut microbiome Peripheral Immune profile change Metabolomics |
3/27/2019 | Recruiting | Western University, Ontario Canada |
| NCT03817125 | Metastatic melanoma | 30 | FMT + Nivolumab | 1b | Naive | Randomized | Not specified | Single | Capsule | Capsule taken QOD x3 Then Qweekly x8 |
1 week prior to | Safety | Microbiome change ORR Immune profile change Survival |
1/28/2019 | Recruiting | MD Anderson Cancer Center, USA |
| NCT04130763 | Anti-PD1-refractory luminal GI cancer | 5 | FMT + Pembrolizumab/Nivolumab | 1 | Refractory | Single arm | Not specified | Not specified | Capsule | Capsule taken QOD x3 Then Qweekly x2 |
Prior to | ORR Safety | Immune profile change Effect on the gut microbiome |
10/1/2019 | Not yet recruiting | Peking University, Beijing, China |
| NCT04116775 | Metastatic castrate-resistant prostate cancer | 32 | FMT + Pembrolizumab + Enzalutamide + Androgen deprivation | 2 | Refractory CRPC patients initiated on Pembrolizumab + Enzalutatmide. who fail to respond at 12 weeks | Single arm | Responder | Pooled | Colonoscopy | Once | 12 weeks post 1st dose | PSA change | Radiographic response rate Progression free survival Overall Survival |
10/1/2019 | Not yet recruiting | VA Portal HealthCare System, Oregon USA |
| NCT04056026 | Metastatic mesothelioma | 1 | FMT+ Pembrolizumab/Nivolumab | 1 | Naïve | Single arm | Healthy | Pooled | Colonoscopy | Single dose | Prior to | Progression free survival | None | 9/18/2018 | Completed | ProgenaBiome, CA USA |
| FMT Directed | for Toxicity | |||||||||||||||
| NCT03819296 | Patients with melanoma or GU cancer who develop ICB-related colitis | 100 | FMT | 1 | ICI treated | Single arm | Healthy | Not specified | Colonoscopy | Not specified | Post | Safety | Change in stool microbiome | 11/15/2019 | Not yet recruiting | MD Anderson Cancer Center, USA |
| NCT04038619 | Patients with GU cancer who develop ICB-related colitis | 40 | FMT + Loperamide | 1 | Prior ICI therapy | Single arm | Healthy | Pooled | Colonoscopy | Once, 15 to 30 minutes | Post | Safety Clinical resolution of colitis | Colitis recurrence at 3 months Endoscopic and histologic remission |
1/1/2020 | Not yet recruiting | MD Anderson Cancer Center, USA |
PSA= Prostate specific antigen, RECIST= Response criteria in solid tumor, iRECIST= Immune-related response criteria in solid tumor, ORR= objective response rate, ICB= Immune checkpoint blockade, CTCAE= Common Terminology Criteria for Adverse Events version 5, CRCP= castrate-resistant prostate cancer, QOD= every other day, QWeekly= Every week, RCT= randomized control trial, FMT= fecal microbiota transplant.