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PICASSO. Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD-1 inhibitors
EU CTIS ID: 2024-516100-42-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 18 to 80
- 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 ≥ 100000/mm3
- Neutrophils ≥ 1500/mm3
You likely can't join if
- Pregnant or breastfeeding women
- Patient on AME (state medical aid) (unless exemption from affiliation)
- Patients guardianship/legal protection/curatorship
- Contraindication to fecal transplantation
- Known hypersensitivity to Normacol or Moviprep® or equivalent patent medicines enema or one of their components
- Fluid-electrolyte disorders with sodium retention (heart failure, hyperaldosteronism, drug-induced edema)
See the full eligibility criteria
Who can join
- Patients aged 18 to 80
- 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 ≥ 100000/mm3
- Neutrophils ≥ 1500/mm3
- Creatinine Clearance ≥ 50mL/mn
- AST ≤ 3N (< 5x ULN in case of liver metastases
- ALT ≤ 3N (< 5x ULN in case of liver metastases)
- Total bilirubin ≤ 1.5N (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Alkaline phosphatase ≤ 3N
- Patients with unresectable or metastatic melanoma
- INR < 1.5 (or within the therapeutic range in patients treated with anticoagulants)
- Prothrombin ≥ 70% (or within the therapeutic range in patients treated with anticoagulants)
- TCA < 1.2 (or within the therapeutic range in patients treated with anticoagulants
- No Hepatocellular insufficiency
- Patients with ECOG performance of 0-2
- Patients able to provide written informed consent
- Patients able to 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)
What rules you out
- Pregnant or breastfeeding women
- Patient on AME (state medical aid) (unless exemption from affiliation)
- Patients guardianship/legal protection/curatorship
- Contraindication to fecal transplantation
- Known hypersensitivity to Normacol or Moviprep® or equivalent patent medicines enema or one of their components
- Fluid-electrolyte disorders with sodium retention (heart failure, hyperaldosteronism, drug-induced edema)
- Recent acute coronary syndrome or unstable ischemic heart disease
- Congestive heart failure ≥ Class III or IV as defined by New York Heart Association
- 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
- Gastrointestinal obstruction or perforation
- Gastric emptying disorders (gastroparesis)
- Antibiotics in the last two weeks prior to the FMT
- Ileus
- Phenylketonuria (due to the presence of aspartame)
- Deficiency in glucose-6-phosphate dehydrogenase (due to the presence of ascorbate)
- -Toxic megacolon, in severe forms of inflammation of the intestinal tract, including Crohn's disease and ulcerative colitis
- Inability to retain enemas
- Expected to require any other form of systemic or localized anti-neoplastic therapy while on study
- Active infection requiring systemic therapy
- Patients with a negative Epstein-Barr virus result
- Active, known or suspected autoimmune disease.except vitiligo and controlled complemented endocrine autoimmune disease
- No health insurance
- Patients already included in a clinical research other than an observational study (e.g: registry, cohort)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.