Plain-English translation of NCT05251389 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This study is testing whether a procedure called fecal microbiota transplantation (FMT)—transferring healthy gut bacteria from donors into your digestive system—can help your body respond better to anti-PD-1 immunotherapy. You would receive bacteria from either a patient who responded well to this treatment or from a patient whose cancer continued to grow despite treatment, combined with your ongoing immunotherapy.
Some patients with advanced melanoma don't respond to immunotherapy, and their cancer continues to grow. Recent research suggests that the types of bacteria living in a patient's gut may affect how well immunotherapy works, so this trial is testing whether transplanting bacteria from responding patients might "reset" the immune system to make the treatment more effective.
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You would receive antibiotics for 4 days to clear your gut, then undergo a bowel cleansing procedure. A doctor would then place the transplanted gut bacteria into your upper digestive system using a camera procedure similar to an endoscopy. You would continue your regular anti-PD-1 immunotherapy treatment throughout. The study would monitor your safety and how well your cancer responds to treatment over time.
AI-generated summary from trial data · Jun 7, 2026 · Not medical advice
Netherlands