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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rhode Island Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brown University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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