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

Primary Purpose

Melanoma Stage Iv, Unresectable Stage III Melanoma

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Fecal Microbiota Transplant (FMT)

About this trial

This is an interventional treatment trial for Melanoma Stage Iv focused on measuring Melanoma, Fecal Microbiota Transplantation, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal Microbiota Transplant (FMT)

Arm Description

FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.

Outcomes

Primary Outcome Measures

Incidence of FMT-related Adverse Events

Number of patients with adverse events that emerged post FMT

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

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT03353402

First Posted

November 20, 2017

Last Updated

April 2, 2019

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03353402

Brief Title

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

Official Title

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 30, 2017 (Actual)

Primary Completion Date

December 30, 2019 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma Stage Iv, Unresectable Stage III Melanoma

Keywords

Melanoma, Fecal Microbiota Transplantation, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fecal Microbiota Transplant (FMT)

Arm Type

Experimental

Arm Description

FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.

Intervention Type

Procedure

Intervention Name(s)

Fecal Microbiota Transplant (FMT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of FMT-related Adverse Events

Description

Number of patients with adverse events that emerged post FMT

Time Frame

4 years

Title

Proper implant engraftment

Description

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

Secondary Outcome Measure Information:

Title

Changes in composition of immune cell population

Description

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

Title

Changes in activity of immune cells

Description

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

Other Pre-specified Outcome Measures:

Title

Objective Response Rate (ORR)

Description

Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST.

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gal N Markel, MD,PhD

Phone

+972.3.530.7093

gal.markel@sheba.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Ben S Boursi, MD

Phone

+972.3.530.2542

Ben.Boursi@sheba.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gal Markel, MD, PhD

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Tel HaShomer

ZIP/Postal Code

5262620

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erez N Baruch, MD

Phone

+972.530.4591

Erez.Baruch@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Ben S Boursi, MD

Phone

+972.530.2542

Ben.Boursi@sheba.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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