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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Sheba Medical Center
Tel Litwinsky, Israel
RECRUITINGIncidence of FMT-related Adverse Events
Number of patients with adverse events that emerged post FMT
Time frame: 4 years
Proper implant engraftment
Comparing of the patients' gut bacterial composition pre and post-FMT and in relation to their donors. Bacterial composition will be quantified by the operational taxonomic unit (OTU) in the stool
Time frame: 4 years
Changes in composition of immune cell population
Changes in the relative abundance of different immune cell population (such as the proportion of CD8+ T cells) pre and post-FMT.
Time frame: 4 years
Changes in activity of immune cells
Changes in levels of proteins that represent immune activity against cancer (such as measurements of blood interferon gamma levels), pre and post FMT
Time frame: 4 years
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