NCT05273255

Fecal Microbiota Transplantation in Patients With Malignancies Not Responding to Cancer Immunotherapy

An Open Label Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients With Malignancies Not Responding to Cancer Immunotherapy (CI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Michael Scharl · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intestinal microbiome forms a symbiotic relationship with the human host and continuously interacts with its immune system. Specific compositions of the intestinal microbiome in patients with cancer have been linked to the response to therapy with cancer immunotherapies (CI), such as immune checkpoint inhibitors (ICIs). The investigators hypothesize that fecal microbiota transplantation (FMT) from patients being responsive to ICI therapy (FMT-Donor) can modulate the intestinal microbiome of patients with CI-refractory malignancies (FMT-Recipients) and render them into responders. Successful proof-of-concept studies showed that reversion from an ICI non-responsive to a responsive disease is indeed possible in melanoma patients after FMT. This trial expands the FMT intervention to patients with any malignancy treated with cancer immunotherapy as a standard of care, to demonstrate the feasibility of this FMT approach as a novel option in cancer therapy.

Conditions

• Cancer
• Fecal Microbiota Transplantation
• Immune Checkpoint Inhibitors
• Immunotherapy

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation (FMT)	Single-dose of fecal microbiota from FMT-Donor transplanted endoscopically to FMT-Recipient in between two cycles of CI.

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-01-04
• Completion: 2024-10-24
• First posted: 2022-03-10
• Last updated: 2025-03-28

Locations

1 site across 1 country: Switzerland