Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

Conditions

Solid Carcinoma

Keywords

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

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

Yanshuang Wei, Lanqun Qin, Xinyu Wu, Dongqing Li, Danping Qian et al. (7 authors)

BMJ Open2025-03-011 citations

10.1136/bmjopen-2024-094366

Fecal microbiota transplantation improves anti-PD-1 inhibitor efficacy in unresectable or metastatic solid cancers refractory to anti-PD-1 inhibitor.

Kim Y, Kim G, Kim S, Cho B, Kim SY, Do EJ, Bae DJ, Kim S, Kweon MN, Song JS, Park SH, Hwang SW, Kim MN, Kim Y, Min K, Kim SH, Adams MD, Lee C, Park H, Park SR.

2024-07-2584 citations

10.1016/j.chom.2024.06.010

Fecal microbiota transplantation combined with anti-PD-1 inhibitor for unresectable or metastatic solid cancers refractory to anti-PD-1 inhibitor.

Sook Ryun Park, Gihyeon Kim, Yun-Jae Kim, Beomki Cho, Sang‐Yeob Kim et al. (10 authors)

Journal of Clinical Oncology2023-06-0115 citations

10.1200/jco.2023.41.16_suppl.105

Interventions

PROCEDUREfecal 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

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

No

Inclusion criteria

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) \-------------------------------------------------------------------------------------------- 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

Design outcomes

Primary

Measure	Time frame	Description
Overall Response Rate	5 years	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)

Countries

South Korea

Contacts

CONTACTSook Ryun Park, M.D, Ph D

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

PRINCIPAL_INVESTIGATORSook Ryun Park, M.D, Ph D

Asan Medical Center, Ulsan University of College of Medicine

Outcome results

None listed