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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT03004183
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADV/HSV-tk — BIOLOGICAL
    Replication-defective recombinant adenovirus vector
  • Valacyclovir — DRUG
    Prodrug of the antiviral drug acyclovir
  • SBRT — RADIATION
    Low-dose SBRT
  • Pembrolizumab — DRUG
    Humanized immunoglobulin G4 anti-programmed death-1 (PD-1) monoclonal antibody

Study Details

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.

Key Dates

Start date
Jul 1, 2017
Status verified
Aug 2024
Primary completion
Jul 22, 2022
Completion
Jan 9, 2024

Study Design

Enrollment
57 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    ADV/HSV-tk (5 x 1011 virus particles) in a 2-mL total volume will be injected intratumorally on Day 0. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days from Day 1 to Day 15. SBRT of 30 Gy (6 Gy X 5 fractions) will be administered over 2 weeks from Day 2 to Day 16. Pembrolizumab (200 mg) will be administered intravenously over 30 minutes every 3 weeks starting on Day 17 and continuing until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 30 days after the last dose of pembrolizumab until disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. Median duration of follow-up was 8.3 months (95% CI 3.0-10.1 months). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Houston Methodist Cancer Center· Houston, TX

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