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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04988841
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • MaaT013 — DRUG
    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)
  • Ipilimumab — DRUG
    Anti cytotoxicT-lymphocyte-associated protein 4 ( immunothérapy)
  • Nivolumab — DRUG
    AntiPD1 ( immunothérapy)
  • MoviPrep — DRUG
    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)
  • Normacol — DRUG
    hypertonic enema solution
  • Placebo of Maat013 — DRUG
    expérimental drug placebo of MaaT013

Study Details

Recent studies suggest that patients with metastatic melanoma whose gut microbiome is colonized by eubiotic bacteria have a stronger anti-cancer response to anti CTLA-4 and anti PD1. The hypothesis of this research is that a pooled standardized fecal microbiome transfer (FMT) will shift melanoma patients' gut microbiome towards a composition close to that associated with a better response, and will therefore increase the response to a combination of anti CTLA-4 and anti PD1, without affecting the safety of these drugs. The present trial is the first randomized trial of FMT in patients with unresectable or metastatic melanoma. It will include patients who have neither been exposed to anti CTLA-4 nor anti PD1 or PDL-1, prior to inclusion in the study. The pooled standardized fecal microbiome transfer administered in this study is an experimental drug MaaT013, a microbiome restoration biotherapeutic, produced by MaaT Pharma, and composed of pooled-donor, full-ecosystem intestinal microbiome. The MaaT013 product has a standardized richness (in number of species present) higher than a product obtained from a mono donor (455 species approximately against 274 on average) and contains bacteria species (mentioned in the rationale) associated with better response to anti- CTLA-4 and anti PD1.

Key Dates

Start date
Jan 20, 2022
Status verified
Jul 2025
Primary completion
Aug 30, 2024
Completion
Apr 22, 2025

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fecal microbiotherapy (MaaT013) associated to ipilimumab and nivolumab
    Fecal microbiotherapy MaaT013 (actif arm) enemas will be administered by nurses, at the hospital, in the dermatology department in which the patients are treated for their melanoma. Nurses will be trained to administer enemas. The enema will be administered to the patient in the left lateral position with instructions to retain it for at least 20 minutes
  • Placebo Comparator: fecal microbiotherapy Placebo associated to ipilimumab and nivolumab
    Placebo fecal microbiotherapy will be administered by nurses, at the hospital, in the dermatology department in which the patients are treated for their melanoma. Nurses will be trained to administer enemas. The enema will be administered to the patient in the left lateral position with instructions to retain it for at least 20 minutes

Primary Outcome Measure

To assess whether the safety of a 23-week treatment with MaaT013, combined with ipilimumab+nivolumab, is different from that of ipilimumab+nivolumab+placebo in patients with melanoma naïve to Ipilimumab and anti-PD1 [ Time Frame: During the 27 weeks of the trial. ]

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