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

NCT05273255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-03-28

No results posted yet for this study

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

BIOLOGICAL

Fecal Microbiota Transplantation (FMT)

Single-dose of fecal microbiota from FMT-Donor transplanted endoscopically to FMT-Recipient in between two cycles of CI.

Sponsors & Collaborators

  • Michael Scharl

    lead OTHER

Principal Investigators

  • Michael Scharl, Prof. Dr. · University Hospital Zurich, University of Zurich

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2024-01-04
Completion
2024-10-24

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273255 on ClinicalTrials.gov