NCT02824965

Pembrolizumab + CVA21 in Advanced NSCLC

A Phase I/II Open-label Trial of Intravenous CAVATAK^TM in Combination With Pembrolizumab for the Treatment of Patients With Advanced NSCLC

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Olivia Newton-John Cancer Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a Phase Ib open-label trial of CAVATAK™ (CVA21) in combination with Pembrolizumab for the treatment of patients with advanced NSCLC. The dose of Pembrolizumab will be fixed at 200mg. Three cohorts (dose levels) of intravenously-delivered CVA21 will be explored, using a standard 3+3 patient dose escalation design. The starting dose of CVA21 will be one log below the 1 x 10\^9 TCID50 dose found to be safe when CVA21 was given alone in an ongoing Phase I study (NCT02043665).

Detailed description

Primary Objective \& Hypothesis (1) Objective: To evaluate the safety of intravenous CVA21 in combination with pembrolizumab in patients with advanced NSCLC. Hypothesis: Pembrolizumab in combination with intravenous CVA21 will be well tolerated in patients with advanced NSCLC. Secondary Objective \& Hypothesis (1) Objective: i. To evaluate the efficacy of intravenous CVA21 in inducing an immune cell rich tumour microenvironment in patients with a baseline biopsy demonstrating a tumour with an immune cell poor microenvironment. ii. To evaluate the efficacy of intravenous CVA21 in combination with pembrolizumab in patients with advanced NSCLC using irRECIST. iii. To evaluate the safety of intravenous CVA21 in combination with pembrolizumab. iv. To identify a safe and potentially effective dose for intravenous CVA21 in combination with intravenous pembrolizumab. v. To serially evaluate the presence of detectable virus and anti-viral antibodies in peripheral blood of the trial participants. Hypothesis: i. CVA21 will induce immune cell infiltration into tumors of patients that lack an immune cell rich micro-environment.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is a selective monoclonal antibody that blocks the interaction between PD1 and its ligands PDL1 and PDL2, resulting in infiltration of tumour specific CD8+ T-cells and ultimately leads to tumour rejection.
BIOLOGICAL	CVA21	CAVATAK is an oncolytic Coxsackie virus that specifically infects and kills ICAM overexpressing tumour cells

Timeline

• Start date: 2017-08-09
• Primary completion: 2021-07-01
• Completion: 2021-10-01
• First posted: 2016-07-07
• Last updated: 2021-07-07

Locations

1 site across 1 country: Australia