Biomarkers For Immune Checkpoint Inhibitors

Study Overview
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Brief Summary
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This is a laboratory, non-treatment study. Immune checkpoint inhibitors are a type of immunotherapy that stimulates a patients immune system to fight their cancer. Immune checkpoint inhibitors are standard, FDA approved treatment for certain types of cancers such as melanoma, lung cancer, kidney cancer and bladder cancer. The laboratories of Dr. Jack Elias and Dr. Chun Geun Lee at Brown University are studying how immune checkpoint inhibitors work.Kintai Therapeutics is a biotech company in Cambridge Massachusetts that will focus on the molecules present in the GI tract, including the stomach, small intestine and colon.

Detailed Description
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Patients who are receiving immune checkpoint inhibitors for their cancer treatment are eligible. Patients will sign informed consent. Ten cc of blood will be drawn before beginning immune checkpoint inhibitors and 10 cc of blood will be drawn 1-4 months after treatment is initiated. Deidentitified blood samples will be sent to the lab of Dr. Jack Elias and Dr. Chun Geul Lee and analyzed for biomarkers. The blood samples will be linked to the patient by a research number. Response to treatment will be correlated to potential biomarkers. The stool samples will be linked to the patient by a research number. Bacterial DNA and RNA may be sequenced and data used to identify bacterial taxa and genes within the stool. In compliance with NIH guidelines, all human DNA data would be removed computationally, and will not be used in any analyses. Small molecules may be profiled with metabolomics. Bacteria may also be isolated from the stool into in vitro culture, and efficacy of single-strains or communities and/or their DNA, RNA, and metabolites on disease models may be assessed.

Official Title
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Biomarkers For Immune Checkpoint Inhibitors

Conditions
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Advanced Cancer, Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced solid tumors initiating treatment with an immune checkpoint inhibitor. No prior immune checkpoint inhibitors Age >18. Signed informed consent Exclusion Criteria: The patient is unwilling or unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine serum predictors of response to immune checkpoint inhibitors at study entry, prior to checkpoint inhibitor therapy | Measure biomarker levels of immune checkpoint inhibitors in blood serum | At study entry, prior to checkpoint inhibitor therapy Anytime between 6-12 weeks after initiating treatment. | 
| To determine serum predictors of response to immune checkpoint inhibitors 4-weeks after initiation of treatment | Measure biomarker levels of immune checkpoint inhibitorsin blood serum | Within 4 weeks after initiation of treatment | 
| To determine serum predictors of response to immune checkpoint inhibitors anytime between 6-12 weeks after initiating treatment. | Measure biomarker levels of immune checkpoint inhibitors in blood serum | 6-12 weeks after initiating treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity. | Measure bacteria and bacterial products in gut micobiome | At study entry, prior to immune checkpoint inhibitor therapy | 
| To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity. | Measure bacteria and bacterial products in gut micobiome | Within 4 weeks after initiation of treatment | 
| To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity. | Measure bacteria and bacterial products in gut micobiome | Anytime between 6-12 weeks after initiating treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Advanced, Solid Tumor, Advanced Solid Tumor