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

Overview

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.

Full Title of Study: “Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Fecal Microbiota Transplant (FMT)
    • FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • A histologically confirmed diagnosis of metastatic melanoma. – Failed at least one line of PD-1 blockade. – ECOG Performance Status 0-2 – Able to provide written informed consent. Exclusion Criteria:

  • Presence of absolute contra-indications to FMT administration. – Severe dietary allergies (e.g. shellfish, nuts, seafood). – Anatomic contra-indications to colonoscopy. – Inability to swallow capsules. – Current participation in a study of an investigational agent. – Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment. – History of bleeding disorder, chronic kidney disease, Inflammatory bowel disease. – History of a major abdominal surgery – Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Gal Markel, Chief Scientist of The Ella Lemelbaum Institute of Immuno-Oncology, Principal Investigator, Associate Professor of Immunology – Sheba Medical Center
  • Overall Official(s)
    • Gal Markel, MD, PhD, Principal Investigator, Sheba Medical Center
  • Overall Contact(s)
    • Gal N Markel, MD,PhD, +972.3.530.7093, gal.markel@sheba.health.gov.il

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.