Clinical trial NCT03353402: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Melanoma Stage Iv
Unresectable Stage III Melanoma
Keywords: Melanoma
Fecal Microbiota Transplantation
Immunotherapy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of FMT-related Adverse Events
timeFrame: 4 years
measure: Proper implant engraftment
timeFrame: 4 years
Secondary outcomes:
measure: Changes in composition of immune cell population
timeFrame: 4 years
measure: Changes in activity of immune cells
timeFrame: 4 years
Other outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 4 years
Locations:
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Gal Markel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: