drugset / Trial / NCT03004183

SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC

NCT03004183

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment before pembrolizumab in patients with metastatic triple negative breast cancer (TNBC) and metastatic non-small cell lung cancer (NSCLC). In situ oncolytic virus therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus valacyclovir therapy.

Timeline

Start
2017-07-01
Primary completion
2022-07-22
Completion
2024-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject HSV-Tk Cell therapy 5e+11 unknown Other
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Valacyclovir Unknown 2 g Oral