2024-516100-42-00招募中2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Safety will be measured by the occurrence of Grade 3 and grade 4 adverse events (AE), as graded by the CTCAE v 5.0 during the 27 weeks of the trial
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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)
结局指标
主要结局
Safety will be measured by the occurrence of Grade 3 and grade 4 adverse events (AE), as graded by the CTCAE v 5.0 during the 27 weeks of the trial
Safety will be measured by the occurrence of Grade 3 and grade 4 adverse events (AE), as graded by the CTCAE v 5.0 during the 27 weeks of the trial
次要结局
- Efficacy will be assessed by the best overall response rate, with confirmation of complete or partial response, rated by Response Evaluation Criteria in Solid Tumors (RECIST v1.1; 19) in the experimental and control arms
- Changes in the tumor micro environment (CD3, CD8, FoxP3, CD56, granzyme B, CD68, CD163, CD20, PD1) pre and post MaaT013 or placebo
- Changes in plasma levels of proteins or metabolites that play a role in immune activity against cancer and/or are associated with gut microbiome composition, pre and post ipilimumab + nivolumab with MaaT013 or placebo
- Changes in peripheral blood immune cell subpopulations pre and post ipilimumab + nivolumab with MaaT013 or placebo
- Changes in gut microbiome and metabolites pre and post MaaT013 or placebo and in patients who met the inclusion criteria, received Ipilimumab+Nivolumab, agreed to have stool microbiome analyses at baseline and week 9, but did not receive MaaT013 or placebo
- Best response rate, either complete or partial, rated by RECIST and iRECIST in patients with disease progression who received placebo and subsequently, MaaT013, in an open-label basis
- Progression-free survival rated by RECIST and iRECIST at week 27, 51
- Overall survival rated by RECIST and iRECIST at week 15, 27, 51
- Best overall response rate, with or without confirmation of complete or partial response, rated by iRECIST and PET scan at weeks 15, 27 and 51 using EORTC criteria
- Disease control rate (complete or partial response or stable disease) rated by RECIST and iRECIST
- Pseudo progression rate evaluated by iRECIST
- The favorable gut microbiome is the one associated with the favorable response to ipilimumab and nivolumab. The description of favorable microbiome will be based upon baseline analyses performed in patients of the placebo arm, but also in patients who met the inclusion criteria, received Ipilimumab+Nivolumab, who consented to have a baseline stool microbiota analysis, but were not included in the randomized trial.
- Best overall response rate, without confirmation of response, rated by RECIST
研究者
Franck Carbonnel
Scientific
Assistance Publique Hopitaux De Paris
研究点 (5)
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