drugset / Trial / NCT03004183
SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC
Phase 2
Completed
57 enrolled
The Methodist Hospital Research Institute
Merck Sharp & Dohme LLC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HSV-Tk | Cell therapy | 5e+11 unknown | Other |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Valacyclovir | Unknown | 2 g | Oral |