Personalizing Immune Checkpoint Inhibitor Therapy

Holy Cross Hospital, Maryland

Status: Withdrawn

Conditions: Lung Cancer Stage IV

Treatments: Other: Blood and tumor tissue analysis, Clinical response.

Study type: Observational

Funder types: Other

Identifiers

NCT03409341

IRB# 2018-02

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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