Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer

Description

PRIMARY OBJECTIVE:

I. To assess phenotypic, transcriptional, and epigenetic profiles of PD-1+ CD8 T cells response in patients with stage IV non-small cell lung cancer (NSCLC) treated with the combination of IL-2 and pembrolizumab.

SECONDARY OBJECTIVE:

I. To evaluate anti-tumor activity of the combination of IL-2 and pembrolizumab by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

II. To evaluate the safety of the combination of IL-2 and pembrolizumab.

OUTLINE:

Patients will be treated with pembrolizumab 200 mg IV once every 3 weeks in combination with IL-2 given at 5 million IU subcutaneously twice daily for 3 weeks (5 days on, 2 days off each week, first dose in clinic and subsequent doses at home). IL-2 will be given only for the three weeks, after which pembrolizumab will be continued as monotherapy at either 200 mg every 3 weeks or 400 mg every 6 weeks.

After completion of the study treatment, patients are followed for up for 6 weeks.