Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
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|ClinicalTrials.gov Identifier: NCT03353402|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : December 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Stage Iv Unresectable Stage III Melanoma||Procedure: Fecal Microbiota Transplant (FMT)||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: Fecal Microbiota Transplant (FMT)
FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.
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.
- Incidence of FMT-related Adverse Events [ Time Frame: 4 years ]Number of patients with adverse events that emerged post FMT
- Proper implant engraftment [ Time Frame: 4 years ]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
- Changes in composition of immune cell population [ Time Frame: 4 years ]Changes in the relative abundance of different immune cell population (such as the proportion of CD8+ T cells) pre and post-FMT.
- Changes in activity of immune cells [ Time Frame: 4 years ]Changes in levels of proteins that represent immune activity against cancer (such as measurements of blood interferon gamma levels), pre and post FMT
- Objective Response Rate (ORR) [ Time Frame: 4 years ]Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353402
|Contact: Erez N Baruch, MD||+972.3.530.4591||Erez.Baruch@sheba.health.gov.il|
|Contact: Ben S Boursi, MD||+972.3.530.2542||Ben.Boursi@sheba.health.gov.il|
|Sheba Medical Center||Recruiting|
|Tel HaShomer, Israel, 5262620|
|Contact: Erez N Baruch, MD +972.530.4591 Erez.Baruch@sheba.health.gov.il|
|Contact: Ben S Boursi, MD +972.530.2542 Ben.Boursi@sheba.health.gov.il|
|Principal Investigator:||Gal Markel, MD, PhD||Sheba Medical Center|