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.

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.

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.