Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

NCT04264975 | Unknown

• 1 other identifier: 2018-0608
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Solid Carcinoma

Keywords

immuno-oncology; immunotherapy; biomarker; fecal microbiota transplantation (FMT); microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fecal microbiota transplantation

EXPERIMENTAL

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

Interventions

fecal microbiota transplantation PROCEDURE

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

Also known as: FMT

Fecal microbiota transplantation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Sook Ryun Park, M.D, Ph D

  Asan Medical Center, Ulsan University of College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sook Ryun Park, M.D, Ph D

CONTACT

+82-2-3010-3210; srpark@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: February 11, 2020
• Study Start: June 4, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)