Microbiome biomarkers and fecal microbiota transplantation to support immunotherapy in solid tumors
Official title: Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology
Run by Asan Medical Center · NCT04264975 · Data updated 2026-11-12
This trial tests whether the gut microbiome can help guide immunotherapy and whether fecal microbiota transplantation can boost immunotherapy in adults with solid cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | immunotherapy, prednisone |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | June 4, 2018 |
| Main results expected | April 30, 2027 |
| Study ends | December 31, 2029 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT04264975 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥19 years) with pathologically confirmed solid cancers who are receiving or about to receive immunotherapy and have measurable or evaluable disease, ECOG 0-2.
✕Probably not a fit
Patients with active infections, uncontrolled autoimmune disease, active HIV/tuberculosis, or a history of recent cancer treatments that would interfere with results may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, single-center, non-randomized study explores two aims: first, to develop microbiome-based biomarkers for patients receiving immunotherapy; second, to test fecal microbiota transplantation as a proof-of-concept in patients treated with immunotherapy for advanced solid tumors. Participants will be adults with pathologically confirmed solid cancers who are either on or about to start immunotherapy. The intervention is fecal microbiota transplantation, with eligibility focused on performance status and measurable disease per RECIST 1.1. The study excludes individuals with recent other cancers requiring treatment, active immunodeficiency, infections including TB or HIV, and certain autoimmune conditions. Lead sponsor is Asan Medical Center in Seoul, with no listed collaborators.
Why it matters
Potential benefit: If successful, the study could identify microbiome biomarkers to personalize immunotherapy and show feasibility for microbiome-based strategies to enhance treatment responses.
How similar studies have gone: Prior work in microbiome and immunotherapy is exploratory but has suggested potential associations; this trial includes a proof-of-concept FMT approach that remains investigational.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Asan Medical Center
Seoul, Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Sook Ryun Park, M.D, Ph D — Asan Medical Center, Ulsan University of College of Medicine
- Study coordinator: Sook Ryun Park, M.D, Ph D
- Email: srpark@amc.seoul.kr
- Phone: +82-2-3010-3210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Imaging with 89Zr-DFO-YS5 to detect cancer
This study tests a new PET radiotracer, 89Zr-DFO-YS5, to see if it can show cancer sites in adults with nerve sheath tumors, bladder cancer, or other solid tumors.
-
MSK-TCR5 in adults with advanced solid tumors that have KRAS/HRAS/NRAS G12D
This study tests MSK-TCR5 to see if it is safe for adults with advanced solid tumors carrying a KRAS, HRAS, or NRAS G12D mutation.
-
Using 18F-TRX to image solid tumors
This trial tests whether the 18F-TRX PET tracer can detect tumors in adults with advanced solid tumors such as high‑grade glioma, clear cell renal cell carcinoma, or metastatic castration‑resistant prostate cancer.
-
PET imaging with [89Zr]DFO-starPEG for solid tumors
We will test a new PET imaging tracer called [89Zr]DFO-starPEG in adults with measurable solid tumors to see if it highlights tumor uptake and is safe.
-
ImmunoPET imaging for solid tumors targeting Trop2
This study is testing a new imaging method to see if it can help diagnose solid tumors like bladder and prostate cancer better than current methods.
-
Testing DM002 in patients with advanced solid tumors
This study is testing a new drug called DM002 to see if it is safe and effective for people with advanced solid tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.