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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 : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Gal Markel, Sheba Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Melanoma Stage Iv Unresectable Stage III Melanoma Procedure: Fecal Microbiota Transplant (FMT) Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of FMT-related Adverse Events [ Time Frame: 4 years ]
    Number of patients with adverse events that emerged post FMT

  2. 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 Outcome Measures :
  1. 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.

  2. 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


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Gal N Markel, MD,PhD +972.3.530.7093 gal.markel@sheba.health.gov.il
Contact: Ben S Boursi, MD +972.3.530.2542 Ben.Boursi@sheba.health.gov.il

Locations
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Israel
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   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Gal Markel, MD, PhD Sheba Medical Center
More Information
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Responsible Party: Prof. Gal Markel, Chief Scientist of The Ella Lemelbaum Institute of Immuno-Oncology, Principal Investigator, Associate Professor of Immunology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03353402    
Other Study ID Numbers: SHEBA-17-3956-GM-CTIL
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Gal Markel, Sheba Medical Center:
Melanoma
Fecal Microbiota Transplantation
Immunotherapy
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas