Clinical trial · Interventional
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients
NCT03353402CI-TRIAL-00037906unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients. FMT includes both colonoscopy and stool capsules.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal Microbiota Transplant (FMT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fecal Microbiota Transplant (FMT)
- description
- FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.
- interventionNames
- Procedure: Fecal Microbiota Transplant (FMT)
Primary outcomes (2)
- measure
- Incidence of FMT-related Adverse Events
- timeFrame
- 4 years
- description
- Number of patients with adverse events that emerged post FMT
- measure
- Proper implant engraftment
- timeFrame
- 4 years
- description
- Comparing of the patients' gut bacterial composition pre and post-FMT and in relation to their donors. Bacterial composition will be quantified by the operational taxonomic unit (OTU) in the stool
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A histologically confirmed diagnosis of metastatic melanoma. * Failed at least one line of PD-1 blockade. * ECOG Performance Status 0-2 * Able to provide written informed consent. Exclusion Criteria: * Presence of absolute contra-indications to FMT administration. * Severe dietary allergies (e.g. shellfish, nuts, seafood). * Anatomic contra-indications to colonoscopy. * Inability to swallow capsules. * Current participation in a study of an investigational agent. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment. * History of bleeding disorder, chronic kidney disease, Inflammatory bowel disease. * History of a major abdominal surgery * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
References
Publications (1)
- DERIVEDVillemin C, Six A, Neville BA, Lawley TD, Robinson MJ, Bakdash G. The heightened importance of the microbiome in cancer immunotherapy. Trends Immunol. 2023 Jan;44(1):44-59. doi: 10.1016/j.it.2022.11.002. Epub 2022 Dec 1. PMID 36464584