A Biomarker Study of Low-Dose IL-2 Plus Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Emory University
Summary
This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improved anti-tumor activity in response to this combination. This study will evaluate T cell function as well as clinical outcomes associated with this combination therapy.
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 wee…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have Stage IV non-small cell lung cancer (NSCLC), based on the 8th edition of the American Joint Committee on Cancer (AJCC) NSCLC Staging System. This includes adenocarcinoma and squamous cell carcinoma. 2. Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 3. No prior therapy for advanced NSCLC. 4. Patients with brain metastasis are eligible if they are asymptomatic or treated and stable. 5. Age greater than or equal to 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance…
Interventions
- BiologicalAldesleukin
Given SC
- BiologicalPembrolizumab
Given IV
Location
- Emory University/Winship Cancer InstituteAtlanta, Georgia