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Immune Checkpoint Inhibitors

Patients receive two applications of capsule FMT with 3-7 days between applications.

Patients receive two applications of placebo capsules with 3-7 days between applications.

Faecal Microbiota Transplantation (FMT)

Placebo

Trine L Laursen, BSc

Christian L Hvas, PhD

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.

This is a double-blind, placebo controlled, randomised trial

FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study

Open access publication, raw data available upon reasonable request and according to data protection regulation.

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.

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.

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.

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.

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.

Number of days until resolution of diarrhea, defined as 3 or fewer Bristol type 6-7 stools per day, lasting a minimum of 48 consecutive hours.

Number of adverse events (AE) during first 6 weeks after intervention treatment. AE's will be graded by CTCAE.

Number of serious adverse events (SAE) during 12 weeks follow-up after the final intervention treatment. SAE's will be graded by CTCAE.

Changes in faecal microbiome composition from baseline to week 6 after the last intervention.

Changes in mucosa-associated microbiome from baseline to week 6 after the last intervention.

Percentual change in faecal-calprotectin from prior to intervention to week 6 after the last intervention.

Changes in blood immunological parameters (including circulating cytokines) from baseline and at week 6 after the last intervention.

Hospitalisation defined as the total number of days hospitalised, during 12 weeks of follow-up.

Mortality during the 12 weeks of follow-up.

Accumulated steroid dose (total dose in mg) during 12 weeks following experimental treatment.

Number of patients resuming immune checkpoint inhibitor therapy during the 12 weeks of follow-up.

Response to immune checkpoint inhibitor therapy defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1 and iRECIST).

Patient and physician perceptions of FMT treatment and the usage for IMC assessed by a patient questionnaire at week 6 and a physician questionnaire.

Changes in health-related quality of life assessed by EQ-5D-5L at baseline and week 6.

Endoscopic response, defined as decrease in Mayo endoscopic score ≥1 grade, at week 6 after the last intervention treatment.

Endoscopic remission, defined as Mayo endoscopic score 0, at week 6 after the last intervention treatment.

Spots Global Cancer Trial Database for faecal microbiota transplantation (fmt)