Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

Solid Carcinoma Clinical Trial

Official title:

Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04264975
• Other study ID #: 2018-0608
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2020
• Source: Asan Medical Center
• Contact: Sook Ryun Park, M.D, Ph D
• Phone: +82-2-3010-3210
• Email: srpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

1. Age = 19 years old

2. Eastern Cooperative Oncology Group performance status 0-2

3. Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

<Exclusion Criteria>

1. 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)

2. A history of active primary immunodeficiency

3. Active infection including tuberculosis or Human Immunodeficiency Virus (HIV)

4. 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)

5. 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>

1. Patients who have partial or complete response to immunotherapy at the time of stool donation

2. No history of exposure to HIV or hepatitis virus within the previous 12 months

3. No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea

4. No current communicable disease

5. No household members with active gastrointestinal infection

6. No history of inflammatory bowel disease

7. No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)

<Inclusion criteria for recipients>

1. Patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis

2. 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

Related Conditions & MeSH terms

• Neoplasms
• Solid Carcinoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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