Clinical trial NCT03409341: Personalizing Immune Checkpoint Inhibitor Therapy
Official title: Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer Stage IV
Lead sponsor: Holy Cross Hospital, Maryland
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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

Eligibility 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

Primary outcomes:
measure: Anti-tumor immune response
timeFrame: 12 months
Secondary outcomes:
measure: Clinical response
timeFrame: 12 months for each subject
measure: Tumor microenvironment
timeFrame: 24 months total study duration
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
Study officials:
References:
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