Biomarkers For Immune Checkpoint Inhibitors

August 11, 2024 updated by: Rhode Island Hospital
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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
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
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
Time Frame: Within 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.
Time Frame: 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.
Time Frame: At study entry, prior to immune checkpoint inhibitor therapy
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.
Time Frame: Within 4 weeks after initiation of treatment
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.
Time Frame: Anytime between 6-12 weeks after initiating treatment.
Measure bacteria and bacterial products in gut micobiome
Anytime between 6-12 weeks after initiating treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

Brown University

Investigators

  • Principal Investigator: Howard Safran, MD, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

April 26, 2024

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Biomarkers For I.C. Inhibitors

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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