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

Sheba Medical Center

Status and phase: Unknown; Phase 1

Conditions: Unresectable Stage III Melanoma; Melanoma Stage Iv

Treatments: Procedure: Fecal Microbiota Transplant (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03353402

SHEBA-17-3956-GM-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Fecal Microbiota Transplant (FMT)

Experimental group

Description:

FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.

Treatment:

Procedure: Fecal Microbiota Transplant (FMT)