Tumour Immunotherapy and Microbiome Analysis

Official Title

Tumour Immunotherapy and Microbiome Analysis

Summary:

The composition of the gut microbiome has been associated with response and the development of toxicities on immune checkpoint inhibitors (ICIs) in multiple tumour types. The aim of this study is to examine the gut microbiome composition in patients undergoing standard of care treatment for advanced/unresectable and/or metastatic solid tumours with ICIs. Fecal samples and peripheral blood samples will be collected to further characterize the diversity of gut bacteria and to study potential mechanisms by which gut bacteria impact the immune response.

Trial Description

Primary Outcome:

• Relative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumours
• Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumours

Secondary Outcome:

• Changes in the composition of the intestinal microbiome induced by ICIs
• Relative abundance of bacterial DNA in peripheral blood samples
• Changes in immune cell subsets in the systemic circulation upon progression on ICIs correlated with changes in microbiome composition
• Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition

This is a prospective study of gut microbial markers. Patients with histologically confirmed advanced/unresectable or metastatic solid tumours who are planned to initiate standard of care ICIs or are undergoing standard of care treatment with ICIs will be approached for participation in the study.

View this trial on ClinicalTrials.gov