OncoMatch/Clinical Trials/NCT05251389
FMT to Convert Response to Immunotherapy
Is NCT05251389 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies non-drug interventions for melanoma stage iii.
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 days (day -5 up until day -2), and undergo bowel clearance on day -1 (in total 1L MoviPrep). The FMT, either derived from donor group R (who showed a good response on anti-PD-1 therapy) or donor group NR (who showed progression on anti-PD-1 therapy), will be performed by a gastroenterologist using esophagogastroduodenoscopy. A total amount of 198mL (containing a total of 60 gram feces) will be used for transplantation. Anti-PD-1 treatment will be continued according to the patient's regular treatment schedule. Evaluation of safety and response to treatment will be performed.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — systemic
requiring systemic treatment with anti-PD-1 ... confirmed disease progression (≥20% increase according to RECIST1.1) on two consecutive scans while on anti-PD-1 treatment
Cannot have received: any treatment for melanoma other than anti-PD-1
Patients who have received treatment for their melanoma other than anti-PD-1 treatment [excluded].
Cannot have received: antibiotics
Patients who received treatment with antibiotics in the three months prior to study enrolment, or patients we are expected to receive systemic antibiotics during the course of this study
Lab requirements
Kidney function
serum creatinine clearance 50ml/min or higher
Liver function
serum alat/asat less than three times the upper limit of normal (uln); total bilirubin less than or equal to 20 micromol/l, except in patients with gilbert's syndrome who must have a total bilirubin less than 50 micromol/l
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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