Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE November 30, 2017
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03353402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 20, 2018)
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.
Original Other Pre-specified Outcome Measures
 (submitted: November 22, 2017)
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)
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
Official Title  ICMJE Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma Stage Iv
  • Unresectable Stage III Melanoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Fecal Microbiota Transplant (FMT)
FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.
Intervention: Procedure: Fecal Microbiota Transplant (FMT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03353402
Other Study ID Numbers  ICMJE SHEBA-17-3956-GM-CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Gal Markel, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gal Markel, MD, PhD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP