CCL21-Gene Modified Dendritic Cell Vaccine and Pembrolizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 36
Summary
- Conditions
- Lung Non-Small Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Dose escalation: To determine the safety and maximum tolerated dose (MTD) of intratumoral injection of autologous dendritic cell-adenovirus CCL21 vaccine (CCL21 gene-modified DC [Ad-CCL21-DC]) when combined with intravenous pembrolizumab in 1) patients with advanced non-small ...
PRIMARY OBJECTIVES: I. Dose escalation: To determine the safety and maximum tolerated dose (MTD) of intratumoral injection of autologous dendritic cell-adenovirus CCL21 vaccine (CCL21 gene-modified DC [Ad-CCL21-DC]) when combined with intravenous pembrolizumab in 1) patients with advanced non-small cell lung cancer (NSCLC) without a sensitizing epidermal growth factor receptor (EGFR) mutation and/or anaplastic lymphoma kinase (ALK) gene rearrangement who have received prior systemic anti-cancer therapy for advanced disease that includes a PD -1 and/or PD-L1 inhibitor or 2) patients who have sensitizing EGFR mutations and/or ALK gene rearrangements and have received prior tyrosine kinase inhibitor therapy. II. Dose expansion: To evaluate the objective response rate (ORR) in subjects treated with the dose established during dose escalation (ExD) of intratumoral injection of Ad-CCL21-DC when administered with intravenous pembrolizumab in 1) patients with advanced non-small cell lung cancer (NSCLC) without a sensitizing epidermal growth factor receptor (EGFR) mutation and/or anaplastic lymphoma kinase (ALK) gene rearrangement who have received prior systemic anti-cancer therapy for advanced disease that includes a PD -1 and/or PD-L1 inhibitor or 2) patients who have sensitizing EGFR mutations and/or ALK gene rearrangements and have received prior tyrosine kinase inhibitor therapy. SECONDARY OBJECTIVES: I. To define the adverse event (AE) profile of intratumoral injection of Ad-CCL21-DC (determined during dose escalation) when administered with intravenous pembrolizumab in 1) patients with advanced non-small cell lung cancer (NSCLC) without a sensitizing epidermal growth factor receptor (EGFR) mutation and/or anaplastic lymphoma kinase (ALK) gene rearrangement who have received prior systemic anti-cancer therapy for advanced disease that includes a PD -1 and/or PD-L1 inhibitor or 2) patients who have sensitizing EGFR mutations and/or ALK gene rearrangements and have received prior tyrosine kinase inhibitor therapy. II. To determine drug target activity by analyzing serial pre- and post-treatment biopsies and blood specimens of intratumoral injection of Ad-CCL21-DC (determined during dose escalation) when administered with intravenous pembrolizumab in 1) patients with advanced non-small cell lung cancer (NSCLC) without a sensitizing epidermal growth factor receptor (EGFR) mutation and/or anaplastic lymphoma kinase (ALK) gene rearrangement who have received prior systemic anti-cancer therapy for advanced disease that includes a PD -1 and/or PD-L1 inhibitor or 2) patients who have sensitizing EGFR mutations and/or ALK gene rearrangements and have received prior tyrosine kinase inhibitor therapy. OUTLINE: This is a dose-escalation study of autologous dendritic cell-adenovirus CCL21 vaccine. Patients receive pembrolizumab intravenously (IV) over 30 minutes followed by autologous dendritic cell-adenovirus CCL21 vaccine by computed tomography (CT)-guided or bronchoscopic intratumoral (IT) injection on days 0, 21, and 42. Patients then receive pembrolizumab every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at day 63 and every 3 months thereafter.
Tracking Information
- NCT #
- NCT03546361
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Merck Sharp & Dohme Corp.
- Lungevity Foundation
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Edward B Garon UCLA / Jonsson Comprehensive Cancer Center