FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.
The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.
Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.
Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or above.
Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.
Disqualifiers
Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
Unable to ingest capsules.
Trial design
Design model
Parallel
Treatments tested in this trial
Faecal Microbiota Transplantation (FMT)
Procedure/SurgeryCapsule FMT
Placebo
Procedure/SurgeryPlacebo capsules
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Faecal microbiota transplantation (FMT)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical remission of immune-mediated diarrhea
Number of patients with steroid-free resolution of diarrhea, defined as \< 3 liquid stools (Bristol \<6) per 24 hours during day 40 and 41 after the last intervention treatment.
Time frame
At 42 days after intervention treatmentSecondary outcomes
1
Remission of diarrhea defined by CTCAE
Number of patients in steroid-free clinical remission of diarrhea 6 weeks (42 days) after the last intervention treatment. Clinical remission is defined as \< 4 stools over baseline per day (CTCAE diarrhea grade 1 or less), at day 40 and 41.
Time frame
At 42 days after intervention treatment2
Remission of colitis defined by CTCAE
Number of patients in steroid-free clinical remission of colitis 6 weeks (42 days) after the last intervention treatment. Clinical remission is defined as asymptomatic in regards to colitis (CTCAE colitis grade 1 or less), at day 40 and 41.
Time frame
At 42 days after intervention treatment3
Therapy response of FMT
Therapy response defined as a decrease of at least 3 points in Simple Clinical Colitis Activity Index (SCCAI) score, at weeks 1, 6 and 12 after the last intervention treatment.
Time frame
Up to 12 weeks after intervention treatment4
Number of days until CTCAE diarrhea grade 1
Number of days until less than 4 stools over baseline per day (CTCAE diarrhea grade 1 or less), lasting a minimum of 48 consecutive hours with no increase in steroid dose in the 12 weeks of follow-up.
Time frame
Up to 12 weeks after intervention treatmentSponsors and contacts
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Source ClinicalTrials.gov