Personalizing Immune Checkpoint Inhibitor Therapy

Withdrawn

• Conditions: Lung Cancer Stage IV

• Registration Number: NCT03409341
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-24
• Study Start: 2019-02-01
• Primary Completion: 2020-01-08
• Status Verified: 2020-09
• Study Completion: 2020-09-22
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-tumor immune response	12 months	Tumor antigen presentation and anti-tumor T-cell response

Secondary Outcome Measures

Name	Time	Method
Clinical response	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	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

Trial Locations

Locations (1)

Holy Cross Hospital; 🇺🇸 Silver Spring, Maryland, United States