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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

Recruiting now NA Last updated 3 December 2025
What this trial tests

NA trial testing fecal microbiota transplantation with Nivolumab in Solid Carcinoma in 50 participants. Currently enrolling.

Timeline
8 March 2023
Primary endpoint
19 August 2026
19 August 2026

Quick facts

Lead sponsorAsan Medical Center
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date8 March 2023
Primary completion19 August 2026
Estimated completion19 August 2026
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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:

Other recruiting trials for Solid Carcinoma

Currently open trials in the same condition.

Other Asan Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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