Clinical trial NCT04204434: Biomarkers For Immune Checkpoint Inhibitors
Official title: Biomarkers For Immune Checkpoint Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Neoplasms
Keywords: Cancer
Advanced
Solid Tumor
Advanced Solid Tumor
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2019-12-19
Enrollment: 119
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 diagnosed with an advanced solid cancer prior to initiating treatment with an immune checkpoint inhibitor are eligible.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine serum predictors of response to immune checkpoint inhibitors at study entry, prior to checkpoint inhibitor therapy
timeFrame: At study entry, prior to checkpoint inhibitor therapy Anytime between 6-12 weeks after initiating treatment.
measure: To determine serum predictors of response to immune checkpoint inhibitors 4-weeks after initiation of treatment
timeFrame: Within 4 weeks after initiation of treatment
measure: To determine serum predictors of response to immune checkpoint inhibitors anytime between 6-12 weeks after initiating treatment.
timeFrame: 6-12 weeks after initiating treatment
Secondary outcomes:
measure: To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity.
timeFrame: At study entry, prior to immune checkpoint inhibitor therapy
measure: To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity.
timeFrame: Within 4 weeks after initiation of treatment
measure: To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity.
timeFrame: Anytime between 6-12 weeks after initiating treatment.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Howard Safran, MD
role: PRINCIPAL_INVESTIGATOR
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