NCT03121417

Nivolumab in Treating Patients With Advanced Metastatic Non-small Cell Lung Cancer

Biomarker-Driven Phase 2 Study of Nivolumab in Advanced Metastatic NSCLC

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying blood and tumor tissue from patients with advanced non-small cell lung cancer who are treated with nivolumab to better understand how nivolumab works. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread by turning on the immune system (T cells). We want to study the effects of nivolumab on the immune system (T cells) by collecting blood samples and samples from patients' tumors.

Detailed description

PRIMARY OBJECTIVE: I. To study the sustained proliferation of programmed cell death protein (PD)-1+Ki-67+cluster of differentiation(CD)8 T cells as a predictive biomarker of response to nivolumab by comparing the response rates to nivolumab treatment between two groups of patients (positive vs negative) stratified by the status of PD-1+Ki-67+CD8 T cells. SECONDARY OBJECTIVES: I. Characterize phenotype of proliferating T cells in peripheral blood in the setting of nivolumab therapy. II. Perform gene expression profiling of activated T cells from peripheral blood. III. Perform T cell receptor (TCR) sequencing of activated T cells from peripheral blood and tumor infiltrating T cells (TILs). IV. Assess pre-treatment biopsies and biopsies at the time of disease progression for tumor infiltrating lymphocytes. V. Determine progression free survival (PFS) and overall survival (OS). OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unexpected toxicity. After completion of study treatment, patients are followed up at 30 and 90 days and then every 3 months for up to 3 years.

Conditions

• Recurrent Non-Small Cell Lung Carcinoma
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	240 mg given IV

Timeline

• Start date: 2017-07-21
• Primary completion: 2019-03-09
• Completion: 2019-03-09
• First posted: 2017-04-20
• Last updated: 2019-05-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study