Clinical trial NCT04579978: Tumor Immunotherapy and Microbiome Analysis
Official title: Tumor Immunotherapy and Microbiome Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Solid Tumor
Keywords: Immune Checkpoint Inhibitor
Microbiome
Immune-Mediated Toxicity
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: University of Toronto
First posted: 2020-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with advanced/unresectable or metastatic solid tumors either planned to start standard of care treatment with ICIs or already on treatment with ICIs.

Brief summary: The composition of the gut microbiome has been associated with response and the development of toxicities on immune checkpoint inhibitors (ICIs) in multiple tumor 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 tumors 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.

Detailed description: This is a prospective study of gut microbial markers. Patients with histologically confirmed advanced/unresectable or metastatic solid tumors 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.

Eligibility criteria: Inclusion Criteria:

* Sign written and voluntary informed consent
* Adult patients aged \>=18, male or female
* Eastern Cooperative Group (ECOG) performance status 0-2
* Histologic diagnosis of an advanced/unresectable or metastatic solid tumor
* Measurable disease as per RECIST 1.1 criteria
* Be suitable for or receiving ICI treatment
* Prior immunotherapy allowed
* Be willing and able to provide fecal and blood specimens for analysis as per protocol

Exclusion Criteria:

* Subjects with a history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator

Primary outcomes:
measure: Relative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
timeFrame: 6 months
measure: Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
timeFrame: 12 months
Secondary outcomes:
measure: Changes in the composition of the intestinal microbiome induced by ICIs
timeFrame: 6 months
measure: Relative abundance of bacterial DNA in peripheral blood samples
timeFrame: 6 months
measure: Changes in immune cell subsets in the systemic circulation upon progression on ICIs correlated with changes in microbiome composition
timeFrame: 2 years
measure: Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Rossanna C. Pezo, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: