NCT05286294

Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders

MITRIC: Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clincal Responders

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Melanoma Stage IV
• Head and Neck Squamous Cell Carcinoma
• Cutaneous Squamous Cell Carcinoma
• MSI-High
• Clear Cell Renal Cell Carcinoma
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant (FMT)	Fecal Microbiota Transplant (FMT)

Timeline

• Start date: 2022-06-28
• Primary completion: 2034-03-31
• Completion: 2034-12-31
• First posted: 2022-03-18
• Last updated: 2025-07-03

Locations

1 site across 1 country: Norway