Trials / Terminated
TerminatedNCT04577729
The IRMI-FMT Trial
INDUCING REMISSION IN MELANOMA PATIENTS WITH CHECKPOINT INHIBITOR THERAPY USING FECAL MICROBIOTA TRANSPLANTATION.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Medical University of Graz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
- First posted
- 2020-10-08
- Last updated
- 2023-07-10
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04577729. Inclusion in this directory is not an endorsement.