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NCT05533983: NIVO-FMT
FMT With Nivolumab in Patients With Advanced Solid Cancers Who Have Progressed During Anti-PD-(L)1 Therapy
NA trial testing fecal microbiota transplantation with Nivolumab in Solid Carcinoma in 50 participants. Currently enrolling.
19 August 2026
Quick facts
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 8 March 2023 |
| Primary completion | 19 August 2026 |
| Estimated completion | 19 August 2026 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- fecal microbiota transplantation with Nivolumab
Conditions studied
- Solid Carcinoma — all drugs for Solid Carcinoma →
Sponsor
Asan Medical Center
Who can join
19 and older, any sex, with Solid Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, open-label, Phase 2 study to evaluate the efficacy and safety of FMT with nivolumab in patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunology and immunotherapy of cholangiocarcinoma.
Greten TF, Schwabe R, Bardeesy N, Ma L, et al · · 2023 · cited 138× · PMID 36697706 · DOI 10.1038/s41575-022-00741-4 -
From chaos to order: optimizing fecal microbiota transplantation for enhanced immune checkpoint inhibitors efficacy.
Lin A, Jiang A, Huang L, Li Y, et al · · 2025 · cited 45× · PMID 39826104 · DOI 10.1080/19490976.2025.2452277 -
Fecal microbiota transplantation: no longer cinderella in tumour immunotherapy.
Yang Y, An Y, Dong Y, Chu Q, et al · · 2024 · cited 43× · PMID 38241975 · DOI 10.1016/j.ebiom.2024.104967 -
Microbiota-centered interventions to boost immune checkpoint blockade therapies.
Almonte AA, Thomas S, Zitvogel L. · · 2025 · cited 12× · PMID 40261296 · DOI 10.1084/jem.20250378 -
Immunotherapy with guts: a review of microbial therapeutic adjuncts for immunotherapy in solid tumors.
Pum K, Lou E, Goffredo P, Jahansouz C, et al · · 2026 · PMID 41967083 · DOI 10.1093/oncolo/oyag131 -
Influence of Gut Microbiota on Response to Immune Check Point Inhibitors in MASLD Patients With HCC: Unraveling the Connection.
Elsheikh M, Ibrahim MA, Fares S, Bhongade M, et al · · 2026 · PMID 41891399 · DOI 10.1002/cam4.71738 -
Gut microbiota drives cancer evolution and therapy resistance.
Min S, Zhang Y, Zhang H, Liu Q. · · 2026 · PMID 41527087 · DOI 10.1186/s12943-025-02564-8
Verify or expand the search:
- PubMed search for NCT05533983
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Carcinoma
Currently open trials in the same condition.
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- NCT06894745 — PET [89Zr]DFO-starPEG in Solid Tumors · Phase 1 · recruiting
- NCT06751329 — A Study of DM002 in Patients With Advanced Solid Tumors · Phase 1 · recruiting
- NCT06475937 — A Study of DM001 in Patients With Advanced Solid Tumors · Phase 1 · recruiting
- NCT06104488 — A Study of Avutometinib for People With Solid Tumor Cancers · Phase 1 · recruiting
Other Asan Medical Center trials
Trials by the same sponsor.
- NCT07530393 — Blood Viscosity and Outcomes After Elective Craniotomy · not yet recruiting
- NCT07010497 — A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Be · Phase 2 · recruiting
- NCT07382505 — Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cerv · not yet recruiting
- NCT07489092 — Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge · NA · recruiting
- NCT07431762 — Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Hear · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05533983 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asan Medical Center
- Last refreshed: 3 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05533983.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing