Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
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.