Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of FMT-related Adverse Events
研究概览
简要总结
Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients.
FMT includes both colonoscopy and stool capsules.
详细描述
This is a phase I single-center study of fecal microbiota transplant (FMT) in melanoma patients who failed at least one line of PD-1 blockade.
Eligible patients must have a disease amenable to biopsy and lack of contra-indications to FMT.
Patients will undergo a baseline evaluation including imaging, tumor biopsy, blood samples and stool studies to confirm suitability for the study.
Eligible patients will undergo FMT. The FMT includes a colonoscopy followed by stool capsules.
Patients will undergo repeated evaluations including follow-up blood, stool and radiological testings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A histologically confirmed diagnosis of metastatic melanoma.
- •Failed at least one line of PD-1 blockade.
- •ECOG Performance Status 0-2
- •Able to provide written informed consent.
排除标准
- •Presence of absolute contra-indications to FMT administration.
- •Severe dietary allergies (e.g. shellfish, nuts, seafood).
- •Anatomic contra-indications to colonoscopy.
- •Inability to swallow capsules.
- •Current participation in a study of an investigational agent.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment.
- •History of bleeding disorder, chronic kidney disease, Inflammatory bowel disease.
- •History of a major abdominal surgery
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
研究组 & 干预措施
Fecal Microbiota Transplant (FMT)
FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.
干预措施: Fecal Microbiota Transplant (FMT) (Procedure)
结局指标
主要结局
Incidence of FMT-related Adverse Events
时间窗: 4 years
Number of patients with adverse events that emerged post FMT
Proper implant engraftment
时间窗: 4 years
Comparing of the patients' gut bacterial composition pre and post-FMT and in relation to their donors. Bacterial composition will be quantified by the operational taxonomic unit (OTU) in the stool
次要结局
- Changes in composition of immune cell population(4 years)
- Changes in activity of immune cells(4 years)
研究者
Prof. Gal Markel
Chief Scientist of The Ella Lemelbaum Institute of Immuno-Oncology, Principal Investigator, Associate Professor of Immunology
Sheba Medical Center