Spots Global Cancer Trial Database for Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy

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Trial Identification

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 ID: NCT03353402

Conditions

Melanoma Stage Iv

Unresectable Stage III Melanoma

Interventions

Fecal Microbiota Transplant (FMT)

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.