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The IRMI-FMT Trial

NCT04577729 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-07-10

No results posted yet for this study

Summary

Aim of the study is to investigate the effect of Fecal Microbiota Transplantation (FMT) and Checkpoint Inhibitor (CI) re-challenge in prior CI refractory patients on Progression free survival (PFS) and tumor using donor stool of former malignant melanoma patients, who have been in remission due to CI treatment for at least 1 year.

Conditions

  • Fecal Microbiota Transplantation
  • Malignant Melanoma Stage III
  • Malignant Melanoma Stage IV

Interventions

PROCEDURE

Allogenic Fecal Microbiota Transplantation

Patients receiving stool from prior malignant melanoma (MM) patients in remission for at least 1 year after Checkpoint Inhibitor Treatment.

PROCEDURE

Autologous Fecal Microbiota Transplantation

Patients receiving their own stool in terms of sham FMT.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2023-06-07
Completion
2023-06-07

Countries

  • Austria

Study Locations

More Related Trials

Entities

Companies

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 NCT04577729 on ClinicalTrials.gov