Personalizing Immune Checkpoint Inhibitor Therapy

September 22, 2020 updated by: Holy Cross Hospital, Maryland

Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors

This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors.

Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize

  • tumor immunogenicity
  • anti-tumor T-cell response
  • effect of checkpoint inhibitors on antigen presentation and T-cell response, and
  • the tumor microenvironment

Planned enrollment:

• Ten subjects with lung cancer

Methods for Informed Consent:

Investigators will approach subjects for informed consent

Study Type

Observational

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
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Holy Cross 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

• Ten subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors

Description

Inclusion Criteria:

  • Subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors
  • Availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy
  • Informed consent

Exclusion Criteria:

• Lack of 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-tumor immune response
Time Frame: 12 months
Tumor antigen presentation and anti-tumor T-cell response
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 12 months for each subject
Clinical response is defined as 50% or greater decrease of the sum of the products of two-dimensional measurements of lesions on imaging within the first year.
12 months for each subject
Tumor microenvironment
Time Frame: 24 months total study duration
Tumor mutation burden from tumor genome landscape using DNA sequencing, tumor transcriptome with RNA sequencing, tumor infiltrating immune cells with flow cytometry
24 months total study duration

Collaborators and Investigators

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

Sponsor

Holy Cross Hospital, Maryland

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)

February 1, 2019

Primary Completion (Actual)

January 8, 2020

Study Completion (Actual)

September 22, 2020

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IRB# 2018-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data sharing: The data generated in this study will be available to The Holy Cross Health Institutional Review Board, Inc., Investigators named in this protocol, and Officials of the FDA and HHS. Published information following completion of the study will be provided to study patients.

IPD Sharing Time Frame

24 months

IPD Sharing Access Criteria

Upon completion, published results will be provided to participants

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

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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