Status:
UNKNOWN
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
Lead Sponsor:
Sheba Medical Center
Conditions:
Melanoma Stage Iv
Unresectable Stage III Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03353402
Start Date
November 30 2017
End Date
December 30 2021
Last Update
April 3 2019
Active Locations (1)
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1
Sheba Medical Center
Tel Litwinsky, Israel, 5262620