CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Fecal Microbiota Transplant with Pembrolizumabdrug
Likely dose
Fecal Microbiota Transplant with Pembrolizumab 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03341143
NCT03341143Phase 2Completed
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Phase II Feasibility Study of Fecal Microbiota Transplant (FMT) in Advanced Melanoma Patients Not Responding to PD-1 Blockade

Zarour, Hassane, MD·interventional·Posted Nov 14, 2017·Updated Oct 30, 2024

In Brief

A Phase 2 clinical trial evaluating Fecal Microbiota Transplant with Pembrolizumab for Melanoma. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The main goal of this research study is to determine if the fecal microbiota transplant (FMT) improves the body's ability to fight your cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 14, 2017
Enrollment StartMar 19, 2018
Primary CompletionSep 30, 2023
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 8.6 years ago

Interventions

Fecal Microbiota Transplant with Pembrolizumabdrug

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).