Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

Обзор

This is an open label, single-center, non-randomized clinical trial on utilization of microbiome as biomarkers and therapeutics in immuno-oncology. This research consists of two parts: part 1: development of microbiome biomarkers for immuno-oncology part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for advanced solid tumor

Вмешательства

• Процедура fecal microbiota transplantation
  Fecal microbiota transplantation (FMT) is the administration of a solution of fecal matter from a donor into the intestinal tract of a recipient in order to directly change the recipient's microbial composition and confer a health benefit

Первичные конечные точки

• Overall Response Rate [Срок оценки: 5 years]

Критерии участия

Part 1: development of microbiome biomarkers

<Inclusion Criteria:> 1.Patients with pathologically confirmed solid cancer who are being treated with immunotherapy or are going to receive immunotherapy

• Age ≥ 19 years old
• Eastern Cooperative Oncology Group performance status 0-2
• Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

<Exclusion Criteria>

• A history of other cancers requiring treatment within the recent 3 years (excepting treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast, or stomach)
• A history of active primary immunodeficiency
• Active infection including tuberculosis or Human Immunodeficiency Virus (HIV)
• Autoimmune disease (excepting type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disease not requiring systemic therapy (such as vitiligo, psoriasis or alopecia)
• Patients who are receiving immunosuppressive medications (excepting topical steroids, systemic steroid ≤10 mg/day prednisone or equivalents, or a brief course of steroids for prophylaxis (e.g., hypersensitivity reaction)

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part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for solid cancers

<Inclusion Criteria for donors>

• Patients who have partial or complete response to immunotherapy at the time of stool donation
• No history of exposure to HIV or hepatitis virus within the previous 12 months
• No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea
• No current communicable disease
• No household members with active gastrointestinal infection
• No history of inflammatory bowel disease
• No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)

<Inclusion criteria for recipients>

• Patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis
• Patients who have disease progression to immunotherapy as one of the following two patterns:

2-1) Patients who have disease progression due to primary resistance to immunotherapy

2-2) Patients who have disease progression following disease stabilization due to secondary resistance to immunotherapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Asan Medical Center — Seoul

Идентификаторы

NCT: NCT04264975 · 2018-0608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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