PICASSO. Prospective randomized trial evaluating the tolerability and efficacy of fecal transplantation in melanoma patients treated with antiCTLA-4 and antiPD1.
Our previous work suggested that metastatic melanoma patients whose gut microbiome is colonized by eubiotic bacteria have a stronger anti-cancer response to ipilimumab and nivolumab. The PICASSO project aims to evaluate the safety and efficacy of fecal microbiota transplantation administered in addition to the usual immunotherapy combining ipilimumab (CTLA-4 inhibitor) and nivolumab (PD-1 inhibitor) treatment, in patients with metastatic melanoma. We will compare fecal transplantation using MaaT013, a drug composed of bacterial taxa obtained from the stools of several healthy donors, with a placebo (a copy of the drug containing no active product).
Coordination: Franck CARBONNEL - Gastroenterology Department, APHP Bic?tre
Partners: Institut Gustave Roussy (C. Robert, N. Chaput) INRAE - Institut Micalis - PhylHom (P. Lepage)