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Clinical Trial Summary

This is a single-arm, single-center, open-label, phase IIa study evaluating the safety, feasibility and efficacy of Faecal Microbiota Transplant (FMT) to cancer patients not responding to ICI therapy, using ICI-responders as donors.


Clinical Trial Description

Immunotherapy with immune checkpoint inhibitors (ICI) has shown remarkable clinical efficacy against several cancer forms. This includes durable responses in patients with metastatic cancers and no other effective treatment options. However, many patients do not respond. This leaves a major challenge; how to turn non-responders into responders. Herein, this challenge is addressed, by attempting to modulate patients' intestinal microbiota through Faecal Microbiota Transplant (FMT). Data from several preclinical and translational studies have indicated that the microbiota composition is important for the effect of ICIs. Moreover, two recent trials exploring FMT for melanoma patients have suggested acceptable safety and a potential clinical benefit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05286294
Study type Interventional
Source Oslo University Hospital
Contact Jon Amund Kyte, MD, Ph.D.
Phone +4722934000
Email jonky@ous-hf.no
Status Recruiting
Phase Phase 2
Start date June 28, 2022
Completion date December 31, 2034

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