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

NCT03004183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-10-15

Study results available
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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.

Conditions

  • Metastatic Non-small Cell Lung Cancer
  • Metastatic Triple-negative Breast Cancer

Interventions

BIOLOGICAL

ADV/HSV-tk

Replication-defective recombinant adenovirus vector

DRUG

Valacyclovir

Prodrug of the antiviral drug acyclovir

RADIATION

SBRT

Low-dose SBRT

DRUG

Pembrolizumab

Humanized immunoglobulin G4 anti-programmed death-1 (PD-1) monoclonal antibody

Sponsors & Collaborators

Principal Investigators

  • Jenny Chang, MD · Houston Methodist Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2022-07-22
Completion
2024-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004183 on ClinicalTrials.gov