NCT03353402

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Melanoma Stage Iv
• Unresectable Stage III Melanoma

Interventions

Type	Name	Description
PROCEDURE	Fecal Microbiota Transplant (FMT)	Patients with metastatic melanoma who responded to immunotherapy will serve as the fecal implant donors. The tested fecal implant will be used for two different products. The first part of the tested stool will be mixed with a saline solution, strained and infused into your bowel using colonoscopy. The second part of the tested stool will be packed into capsules. These stool capsules are at the size of standard drug-containing capsules and can be swallowed in a standard manner. Stool capsules are a common method of FMT and has been used worldwide for several years. After the colonoscopy, you will be asked to swallow the capsules. Swallowing the capsules will be conducted at the clinic, and does not require any additional procedures.

Timeline

• Start date: 2017-11-30
• Primary completion: 2019-12-30
• Completion: 2021-12-30
• First posted: 2017-11-27
• Last updated: 2019-04-03

Locations

1 site across 1 country: Israel