Fecal Microbiota Transplant (FMT) in Melanoma Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 19, 2018

Primary Completion Date

September 30, 2023

Study Completion Date

September 30, 2024

Conditions
Melanoma
Interventions
DRUG

Fecal Microbiota Transplant with Pembrolizumab

"FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.~Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4)."

Trial Locations (1)

15232

UPMC Hillman Cancer Center, Pittsburgh

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Zarour, Hassane, MD

OTHER

NCT03341143 - Fecal Microbiota Transplant (FMT) in Melanoma Patients | Biotech Hunter | Biotech Hunter