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Personalizing Immune Checkpoint Inhibitor Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409341
Recruitment Status : Withdrawn (No enrollment)
First Posted : January 24, 2018
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Holy Cross Hospital, Maryland

Brief Summary:
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.

Condition or disease Intervention/treatment
Lung Cancer Stage IV Other: Blood and tumor tissue analysis, Clinical response.

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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : January 8, 2020
Actual Study Completion Date : September 22, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Blood and tumor tissue analysis, Clinical response.
    DNA sequencing and functional testing of peripheral blood mononuclear cells. DNA and RNA sequencing and immune cell analysis of tumor. Clinical response at 12 months.


Primary Outcome Measures :
  1. Anti-tumor immune response [ Time Frame: 12 months ]
    Tumor antigen presentation and anti-tumor T-cell response


Secondary Outcome Measures :
  1. 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.

  2. 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


Biospecimen Retention:   Samples With DNA
  1. Peripheral blood samples will be used to evaluate immune cell anti-tumor response, and DNA sequence.
  2. A sample of tumor tissue excised for diagnostic biopsy will be used to evaluate tumor immunogenicity, tumor transcriptome, tumor infiltrating immune cells, and tumor DNA sequence.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409341


Locations
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United States, Maryland
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
Holy Cross Hospital, Maryland
Publications:

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Responsible Party: Holy Cross Hospital, Maryland
ClinicalTrials.gov Identifier: NCT03409341    
Other Study ID Numbers: IRB# 2018-02
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 24 months
Access Criteria: Upon completion, published results will be provided to participants

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No