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

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients

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.