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Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy

Melanoma Stage Iv Clinical Trial

Official title:
Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients

Clinical Trial Summary

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients.

FMT includes both colonoscopy and stool capsules.

Clinical Trial Description

This is a phase I single-center study of fecal microbiota transplant (FMT) in melanoma patients who failed at least one line of PD-1 blockade.

Eligible patients must have a disease amenable to biopsy and lack of contra-indications to FMT.

Patients will undergo a baseline evaluation including imaging, tumor biopsy, blood samples and stool studies to confirm suitability for the study.

Eligible patients will undergo FMT. The FMT includes a colonoscopy followed by stool capsules.

Patients will undergo repeated evaluations including follow-up blood, stool and radiological testings.

The study will be conducted over a 24-week period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03353402
Study type Interventional
Source Sheba Medical Center
Contact Gal N Markel, MD,PhD
Phone +972.3.530.7093
Email gal.markel@sheba.health.gov.il
Status Recruiting
Phase Phase 1
Start date November 30, 2017
Completion date December 30, 2021
View Details
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