drugset / Trial / NCT02831933

Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma

NCT02831933

Phase 2 Terminated 11 enrolled Eric Bernicker, MD
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. In situ gene therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy.

Timeline

Start
2017-02-15
Primary completion
2020-11-05
Completion
2020-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject HSV-Tk Cell therapy 5e+11 vg Other
Subject Valacyclovir Unknown 2 g Oral
Background Nivolumab Monoclonal antibody 480 mg Intravenous