drugset / Trial / NCT02831933
Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HSV-Tk | Cell therapy | 5e+11 vg | Other |
| Subject | Valacyclovir | Unknown | 2 g | Oral |
| Background | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |