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

Korábbi kezelés

• Antibiotics in the last two weeks prior to the FMT
• Expected to require any other form of systemic or localized anti-neoplastic therapy while on study
• Contraindication to fecal transplantation

Más betegség

• Active infection requiring systemic therapy.
• Active, known or suspected autoimmune disease.
• Known hypersensitivity to Normacol or Moviprep® or equivalent patent medicines enema or one of their components.
• Recent acute coronary syndrome or unstable ischemic heart disease
• Congestive heart failure ≥ Class III or IV as defined by New York Heart Association
• Gastrointestinal obstruction or perforation
• Gastric emptying disorders (gastroparesis),
• Toxic megacolon, in severe forms of inflammation of the intestinal tract, including Crohn's disease and ulcerative colitis.

Laborértékek

• Fluid-electrolyte disorders with sodium retention (heart failure, hyperaldosteronism, drug-induced edema)
• Hypersensitivity to the active substances or to any of the excipients: Aspartame (E951), Acesulfame, potassium (E950), lemon flavor (maltodextrin, citral, lemon essential oil, lime essential oil, xanthan gum, vitamin E)
• Deficiency in glucose-6-phosphate dehydrogenase (due to the presence of ascorbate),

Egyéb

• Pregnant or breastfeeding women
• Inability to retain enemas
• No health insurance,
• Patients already included in a clinical research other than an observational study (e.g: registry, cohort).
• Patient on AME (state medical aid) (unless exemption from affiliation)
• Patients guardianship/legal protection/curatorship
• Ileus,
• Phenylketonuria (due to the presence of aspartame),

• Patients aged 18 to 80
• Patients with unresectable or metastatic melanoma
• Patients with ECOG performance of 0-2
• Patients able to provide written informed consent and understand the risks associated with MaaT013
• Have measurable disease as per RECIST version 1.1, on a tumor evaluation (either CT scan, physical evaluation or ultrasonography) performed less than 2 weeks before screening visit
• Requiring a treatment with Ipilimumab and PD1 inhibitor (Nivolumab) and having no contraindication to these drugs nor to their excipients
• Patients unexposed to ipilimumab and anti PD1 or anti PDL1 except if they have received it in the adjuvant setting (if the last dose of Ipilimumab® or anti PD1 or anti PDL1 was received at least 6 months before randomization).
• Negative pregnancy test (serum)
• Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab, ipilimumab and 6 months after the last dose of study treatment (ie, 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo approximately five half-lives)
• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab, ipilimumab and 7 months after the last dose of study treatment {i.e., 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five half-lives.}
• Hemoglobin ≥9 g/dL
• Platelets ≥ 100000mm3
• Neutrophils ≥ 1500/mm3
• Creatinine Clearance ≥ 50mL/mn
• AST ≤ 3N
• ALT ≤ 3N
• Total bilirubin ≤ 1.5N (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
• Alkaline phosphatase ≤ 3N
• INR < 1.5
• Prothrombin ≥ 70%
• TCA < 1.2
• No Hepatocellular insufficiency