Clinical trial NCT05102773: The Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma Patients
Official title: A Pilot Study of the Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Pathologic Stage IV Cutaneous Melanoma AJCC v8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage III, IV melanoma, scheduled to receive pembrolizumab or nivolumab at Ohio State University, Comprehensive Cancer Center.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Baseline microbiome alpha diversity in responders versus (vs) non-responders
timeFrame: At 12 weeks
measure: Baseline microbiome alpha diversity in patients prescribed corticosteroids vs those who were not prescribed corticosteroids
timeFrame: Within the 12-week treatment window
Secondary outcomes:
measure: Recruitment rates for longitudinal biospecimen collection, including stool, in melanoma patients
timeFrame: 12 weeks
measure: Compliance rates for longitudinal biospecimen collection, including stool, in melanoma patients
timeFrame: 12 weeks
Other outcomes:
measure: Microbes as significant predictors in logistic regressions where the outcomes are binary (clinical response or treatment toxicity requiring corticosteroids), with the inputs as relative abundances of individual microbes
timeFrame: At baseline, 12 weeks, or at corticosteroid prescription
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Daniel Spakowicz, PhD
role: PRINCIPAL_INVESTIGATOR
References: