Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-09 @ 11:12 PM
Study NCT ID:
NCT03353402
Status:
UNKNOWN
Last Update Posted:
2019-04-03
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: