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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03353402 |
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Date of registration:
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20/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
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Scientific title:
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Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients |
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Date of first enrolment:
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November 30, 2017 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03353402 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Israel
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Contacts
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Name:
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Gal N Markel, MD,PhD |
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Address:
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Telephone:
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+972.3.530.7093 |
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Email:
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gal.markel@sheba.health.gov.il |
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Affiliation:
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Name:
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Gal Markel, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheba Medical Center |
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Name:
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Erez N Baruch, MD |
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Address:
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Telephone:
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+972.530.4591 |
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Email:
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Erez.Baruch@sheba.health.gov.il |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Melanoma Stage Iv
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Unresectable Stage III Melanoma
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Intervention(s)
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Procedure: Fecal Microbiota Transplant (FMT)
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Primary Outcome(s)
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Proper implant engraftment
[Time Frame: 4 years]
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Incidence of FMT-related Adverse Events
[Time Frame: 4 years]
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Secondary Outcome(s)
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Changes in activity of immune cells
[Time Frame: 4 years]
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Changes in composition of immune cell population
[Time Frame: 4 years]
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Secondary ID(s)
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SHEBA-17-3956-GM-CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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