The Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma Patients

The Ohio State University

Status: Completed

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8

Treatments: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05102773

NCI-2020-01625 (Registry Identifier)

OSU-19125

Details and patient eligibility

About

This pilot trial studies the effect of the microbiome on immune checkpoint inhibitors response in patients with melanoma by collecting stool and blood samples. Gut microbiome plays a critical role in response to immune checkpoint inhibitors. Studying the change in an individual's microbiome due to corticosteroid use may help researchers to determine whether an individual's microbiome can predict their response and toxicity to immune checkpoint inhibitors.

Full description

PRIMARY OBJECTIVE:

I. To determine if the microbiome alpha-diversity is predictive of response (Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1) at a 12-week computed tomography (CT) scan or toxicity.

SECONDARY OBJECTIVE:

I. To determine the recruitment and compliance rates for longitudinal biospecimen collection, including stool, in melanoma patients.

EXPLORATORY OBJECTIVE:

I. To determine if individual microbes or their changes in relative abundance are predictive of response or toxicity.

OUTLINE:

Patients complete a Food Frequency Questionnaire (FFQ) at baseline, undergo collection of stool samples at baseline, within 2 days of starting corticosteroid treatment (if applicable), when asked for a control sample, and at 12 weeks, and undergo collection of blood samples and computed tomography (CT) at baseline and 12 weeks.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible patients include adults with stage III, IV melanoma, to be treated with pembrolizumab or nivolumab, regardless of other concurrent therapy or line of treatment

Exclusion criteria

• Patients will be excluded if they are undergoing active systemic or oral corticosteroid use at start of immune checkpoint inhibitors (ICI) cycle 1, with the exception of adrenal replacement dosing.

Trial design

88 participants in 1 patient group

Ancillary-correlative (questionnaire, sample collection, CT)

Description:

Patients complete a FFQ at baseline, undergo collection of stool samples at baseline, within 2 days of starting corticosteroid treatment (if applicable), when asked for a control sample, and at 12 weeks, and undergo collection of blood samples and CT at baseline and 12 weeks.

Treatment:

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Procedure: Computed Tomography

Procedure: Biospecimen Collection