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NCT Number: NCT04204434

Biomarkers For Immune Checkpoint Inhibitors

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.

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Key information

Conditions

Advanced Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rhode Island Hospital, Providence, Rhode Island, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To determine serum predictors of response to immune checkpoint inhibitors at study entry, prior to checkpoint inhibitor therapy

    Time frame: At study entry, prior to checkpoint inhibitor therapy Anytime between 6-12 weeks after initiating treatment.

    Measure biomarker levels of immune checkpoint inhibitors in blood serum

  2. To determine serum predictors of response to immune checkpoint inhibitors 4-weeks after initiation of treatment

    Time frame: Within 4 weeks after initiation of treatment

    Measure biomarker levels of immune checkpoint inhibitorsin blood serum

  3. To determine serum predictors of response to immune checkpoint inhibitors anytime between 6-12 weeks after initiating treatment.

    Time frame: 6-12 weeks after initiating treatment

    Measure biomarker levels of immune checkpoint inhibitors in blood serum

Secondary outcomes

  1. To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity.

    Time frame: At study entry, prior to immune checkpoint inhibitor therapy

    Measure bacteria and bacterial products in gut micobiome

  2. To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity.

    Time frame: Within 4 weeks after initiation of treatment

    Measure bacteria and bacterial products in gut micobiome

  3. To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity.

    Time frame: Anytime between 6-12 weeks after initiating treatment.

    Measure bacteria and bacterial products in gut micobiome

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Brown University

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2024
First posted
Dec 19, 2019
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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