Personalizing Immune Checkpoint Inhibitor Therapy
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|ClinicalTrials.gov Identifier: NCT03409341|
Recruitment Status : Withdrawn (No enrollment)
First Posted : January 24, 2018
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment|
|Lung Cancer Stage IV||Other: Blood and tumor tissue analysis, Clinical response.|
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
• Ten subjects with lung cancer
Methods for Informed Consent:
Investigators will approach subjects for informed consent
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
- 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.
- Anti-tumor immune response [ Time Frame: 12 months ]Tumor antigen presentation and anti-tumor T-cell response
- 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.
- 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
- Peripheral blood samples will be used to evaluate immune cell anti-tumor response, and DNA sequence.
- 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.
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
|United States, Maryland|
|Holy Cross Hospital|
|Silver Spring, Maryland, United States, 20910|