Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 20, 2022

Primary Completion Date

August 30, 2024

Study Completion Date

April 22, 2025

Conditions
Melanoma
Interventions
DRUG

MaaT013

study is an experimental drug , produced by MaaT Pharma, and composed of pooled-donor, full-ecosystem intestinal microbiome (455 species approximately against 274 on average)

DRUG

Ipilimumab

Anti cytotoxicT-lymphocyte-associated protein 4 ( immunothérapy)

DRUG

Nivolumab

AntiPD1 ( immunothérapy)

DRUG

MoviPrep

Osmotic laxative solution : patients take a single dose of two liters of Moviprep® or equivalent the night before the first administration of experimental treatment (Fecal microbiota transfer or placebo)

DRUG

Normacol

hypertonic enema solution

DRUG

Placebo of Maat013

expérimental drug placebo of MaaT013

Trial Locations (5)

44000

Hôpital Nantes Hôtel Dieu, Nantes

44093

Hôpital Lille, Lille

75010

Hôpital Saint Louis, Paris

92100

Ambroise Paré, Boulogne-Billancourt

94800

Hôpital Gustave Roussy, Villejuif

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER