Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

Study Overview
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Brief Summary
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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

Official Title
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Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

Conditions
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Solid Carcinoma

Intervention / Treatment
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* Procedure: fecal microbiota transplantation


Participation Criteria
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Eligibility Criteria
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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) -------------------------------------------------------------------------------------------- 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal microbiota transplantation<br>Fecal microbiota transplantation in patients who have advanced solid cancer with primary (group 1) or secondary resistance (group 2) to immuno-oncology | Procedure: fecal microbiota transplantation<br>* 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<br>* Other names: FMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | the proportion of patients who have a partial or complete response to therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 or immune RECIST(iRECIST) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immuno-oncology, immunotherapy, biomarker, fecal microbiota transplantation (FMT), microbiome