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NCT05102773 | COMPLETED | Clinical Stage IV Cutaneous Melanoma AJCC v8

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

Ohio State University Comprehensive Cancer Center

Information provided by (Responsible Party):

Daniel Spakowicz

Brief Summary:

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.

Condition or disease

Clinical Stage IV Cutaneous Melanoma AJCC v8

Pathologic Stage IV Cutaneous Melanoma AJCC v8

Intervention/treatment

Biospecimen Collection

Computed Tomography

Laboratory Biomarker Analysis

Questionnaire Administration

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 88 participants
Official Title : A Pilot Study of the Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma
Actual Study Start Date : 2020-02-10
Estimated Primary Completion Date : 2022-05-05
Estimated Study Completion Date : 2022-05-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
The Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma Patients

Location Details

NCT05102773

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Locations

Not yet recruiting

United States, Ohio

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210