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Immunomodulating Agents

Fecal Microbiota Transplant (FMT)

Jon Amund Kyte, MD, Ph.D.

Andreas Ullern, MD

Jon Amund Kyte, MD Ph.D.

This is a single-arm, single-center, open-label, phase IIa study evaluating the safety, feasibility and efficacy of Faecal Microbiota Transplant (FMT) to cancer patients not responding to ICI therapy, using ICI-responders as donors.

Immunotherapy with immune checkpoint inhibitors (ICI) has shown remarkable clinical efficacy against several cancer forms. This includes durable responses in patients with metastatic cancers and no other effective treatment options. However, many patients do not respond. This leaves a major challenge; how to turn non-responders into responders. Herein, this challenge is addressed, by attempting to modulate patients' intestinal microbiota through Faecal Microbiota Transplant (FMT). Data from several preclinical and translational studies have indicated that the microbiota composition is important for the effect of ICIs. Moreover, two recent trials exploring FMT for melanoma patients have suggested acceptable safety and a potential clinical benefit.

Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clinical Responders

MITRIC: Microbiota Transplant to Cancer Patients Who Have Failed Immunotherapy Using Faeces From Clincal Responders

Immunological changes in blood (PBMC, serum/plasma), gut and tumor tissue

Microbial gut composition, tumor tissue, blood and gut will be characterized and correlated with treatment outcome. Assessment will include baseline profile and changes after FMT

T cell receptor binding and T cell reactivity to selected peptides

Comparison of tumor biopsies at baseline and later time points, by gene and protein profiling

Safety of the intervention (FMT) as assessed by the incidence, nature, and severity of Adverse Events (AE) according to NCI CTCAE, version 5.0

Objective Tumor Response Rate (ORR) as assessed by iRECIST in FAS

The percentage of included patients that receive i) at least two FMT, ii) the scheduled number of FMT until End of Intervention (EOI)

Comparison of the patients' gut bacterial composition before and after FMT and in relation to their donors

Patient reported outcomes (PRO) as assessed by EORTC quality of life questionnaire (QLQ-C30)

Patient reported outcomes (PRO) as assessed by Chalder Fatigue Questionnaire (FQ)

Patient reported outcomes (PRO) as assessed by an 11-point Numerical Rating Scale (NRS) for pain intensity

Spots Global Cancer Trial Database for fecal microbiotal transplant (fmt)