FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

Launched by UNIVERSITY OF AARHUS · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for patients who are experiencing diarrhea and colitis (inflammation of the colon) as a side effect from cancer treatments known as immune checkpoint inhibitors. The researchers want to see if a procedure called fecal microbiota transplantation (FMT), which involves taking healthy bacteria from a donor's stool and putting it into the patient's digestive system, can help improve these symptoms. The study will randomly assign participants to receive either the FMT treatment or a placebo (a dummy treatment that looks the same but has no active ingredients) to see if FMT can help them feel better.

To join the trial, participants must be at least 18 years old and have a confirmed diagnosis of either malignant melanoma or kidney cancer. They should have been receiving treatment with immune checkpoint inhibitors in the last eight weeks and be experiencing significant diarrhea. Participants will take capsules containing either the FMT or placebo, in addition to their usual treatment. The trial is currently recruiting, and it’s important to note that people with certain infections, those who are pregnant or breastfeeding, or those who can’t take capsules will not be eligible to participate.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or above.
• • 2. Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
• • 3. Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
• • 4. Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.
• • 5. Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.
• • 6. Signed written informed consent.
• Exclusion Criteria:
• • 1. Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
• • 2. Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
• • 3. Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
• • 4. Unable to ingest capsules.
• • 5. Unable to understand written or oral patient information.