FMT to Convert Response to Immunotherapy

In this study the aim is to investigate whether transfer of the microbiota of either responder or non-responder patients via fecal microbiotica transplantation (FMT) can convert the response to immunotherapy in immune checkpoint inhibitors (ICI) refractory metastatic melanoma patients. This is a randomized double-blind intervention phase Ib/IIa trial in ICI refractory metastatic melanoma patients receiving either FMT of an ICI responding or FMT from an ICI non-responding donor, in combination with ICI. Following randomization, patients will receive vancomycin 250 mg, four times daily for 4 d

Trial Details

NCT ID
NCT05251389
Phase
PHASE1 / PHASE2
Sponsor
The Netherlands Cancer Institute
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Fecal microbiota transplantation
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969

Key Eligibility Criteria

  • Patients should be 18 years or older
  • Patients have pathologically confirmed advanced stage cutaneous melanoma (stage III or IV) requiring systemic treatment with anti-PD-1
  • In case of stage IV disease, only patients with M1a or M1b disease are eligible.
  • Patients have confirmed disease progression (≥20% increase according to RECIST1.1) on two consecutive scans with a four week interval while on anti…

For full eligibility, visit ClinicalTrials.gov.

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