At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic TNBC that is relapsed/refractory to standard of care, OR histologically/cytologically confirmed metastatic NSCLC that is immunotherapy and chemotherapy naïve OR has received ≤1 cycle of platinum-containing chemotherapy
- ✓EGFR/ALK mutation-negative NSCLC or NSCLC with EGFR/ALK mutations that have failed FDA-approved targeted therapy for these aberrations is eligible
- ✓Measurable disease per RECIST 1.1 with target lesion ≥1 cm suitable for SBRT and non-target visceral metastatic lesion ≥1 cm for abscopal effect evaluation
- ✓Age ≥18 years
- ✕Target lesion <1 cm or large central lung lesions, or bone metastases are only available non-target lesions
- ✕Known active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable ≥4 weeks without steroids)
- ✕TNBC cohort: prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
- ✕TNBC cohort: prior immunomodulatory or immunotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Oncolytic Virus Therapy in Metastatic Triple Negative Breast Cancer and Metastatic Non-Small Cell Lung Cancer Followed by Pembrolizumab
In Brief
A Phase 2 clinical trial evaluating ADV/HSV-tk, Valacyclovir, and 2 other interventions for Metastatic Non-small Cell Lung Cancer and Metastatic Triple-negative Breast Cancer. Completed, enrolled 57 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Replication-defective recombinant adenovirus vector
Prodrug of the antiviral drug acyclovir
Low-dose SBRT
Humanized immunoglobulin G4 anti-programmed death-1 (PD-1) monoclonal antibody