Microbial Diversity Between Inflamed and Non-inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis
Microbial Diversity Between Inflamed and Non-inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis
This study determines microbial diversity between inflamed and non-inflamed skin of patients
 with immune checkpoint inhibitor-induced dermatitis. Skin has millions of bacteria. When
 treated with an immunotherapy agent, skin issues like a rash are common, occurring in up to
 45% of patients. This study finds out if the type of bacteria on skin is different between
 the affected and unaffected skin in patients who have this treatment-related rash and also
 compares the immune cells found in the skin tissue to those seen in the blood.
PRIMARY OBJECTIVE:

 I. To determine if skin microbial diversity (estimated by the Shannon Index) significantly
 differs between inflamed and non-inflamed skin from patients who have immune checkpoint
 inhibitor (ICI)-induced dermatitis.

 SECONDARY OBJECTIVES:

 I. To investigate if certain bacterial species and strains are present in higher
 concentrations of inflamed versus non-inflamed skin of patients with ICI-induced dermatitis.

 II. To compare the immune cell phenotypes of inflamed and non-inflamed skin from patients who
 have ICI-induced dermatitis.

 III. To characterize the immune cell phenotype in the peripheral blood in patients who have
 ICI-induced dermatitis.

 IV. To elucidate any association between the skin microbial diversity and response to
 immunotherapy, characterized by Response Evaluation Criteria in Solid Tumors (RECIST)
 criteria (e.g., durable complete response [CR] versus partial response [PR] versus stable
 disease [SD] versus primary progressive disease).

 V. To ascertain if higher concentrations of certain bacterial species are associated with a
 response to immunotherapy, characterized by both RECIST and immune response criteria.

 VI. To evaluate associations between the non-inflamed skin flora and cancer subtypes (e.g.,
 renal cell carcinoma, bladder cancer, lung cancer).

 VII. To examine if skin microbiome is associated with specific demographic characteristics
 such as age and gender.

 OUTLINE:

 Patients undergo punch biopsies of inflamed and non-inflamed skin and a blood sample
 collection.
Inclusion Criteria:

 -  Patients receiving treatment with any of the Food and Drug Administration (FDA)
 approved monoclonal antibodies that block CTLA-4, PD-1, PD-L1, or any combination
 thereof

 -  Patients recommended to undergo skin biopsy due to a clinical diagnosis of ICI-induced
 dermatitis as part of routine and standard clinical care are eligible

 -  Patients must be age 18 or older

 -  Eastern Cooperative Oncology Group (ECOG) performance status < 2

 -  Measurable disease as per RECIST 1.1

 -  Patients must be able to personally sign and date informed consent indicating that the
 patient has been informed of all pertinent aspects of the study are eligible

 Exclusion Criteria:

 -  Patients taking antibiotics or who plan to begin taking antibiotics

 -  Use of topical or systemic steroids within the past 14 days. Inhaled steroids are
 permitted

 -  Known medical condition (e.g. a disease associated with chronic skin inflammation such
 as atopic dermatitis or psoriasis) that, in the investigator's opinion, would increase
 the risk associated with study participation or interfere with the interpretation of
 results

 -  Not recovered to non-dermatologic =< grade 1 toxicities related to any prior therapy

 -  Pregnant woman will not be enrolled in this study. It is a regulatory requirement that
 for studies that carry no prospect of benefit to the woman, the research can only
 enroll pregnant women if the resulting knowledge cannot be obtained by any other
 means. In this study, there is no prospect of direct benefit to the pregnant women

 -  Patients with human immunodeficiency virus (HIV), hepatitis B, or C will be excluded
 from this study

 -  Any other condition that would, in the Investigator's judgment, contraindicate the
 patient's participation in the clinical study due to safety concerns or compliance
 with clinical study procedures (including compliance issues related to
 feasibility/logistics)