NCT03409341

Personalizing Immune Checkpoint Inhibitor Therapy

Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Holy Cross Hospital, Maryland · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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

Conditions

• Lung Cancer Stage IV

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-01-08
• Completion: 2020-09-22
• First posted: 2018-01-24
• Last updated: 2020-09-24

Locations

1 site across 1 country: United States