Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma

Part of paid clinical trials in Houston, Texas.

Sponsor
Eric Bernicker, MD
Study ID
NCT02831933
Phase
PHASE2
Status
Terminated

Conditions

  • Lung Squamous Cell Carcinoma Stage IV
  • Metastatic Uveal Melanoma
  • Nonsquamous Nonsmall Cell Neoplasm of Lung

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
  • nivolumab — DRUG
    Fully human immunoglobulin (Ig) G4 anti-PD-1 monoclonal antibody

Study Details

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.

Key Dates

Start date
Feb 15, 2017
Status verified
Aug 2023
Primary completion
Nov 5, 2020
Completion
Nov 5, 2020

Study Design

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

Arms

  • Experimental: Experimental
    ADV/HSV-tk (5 x 1011 viral particles) in a 2-mL total volume will be injected intratumorally on day 0 of the study. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days. Valacyclovir treatment will be administered 24 hours after the gene vector injection from day 1 to day 15 of the study. SBRT of 30 gray (Gy; 6 Gy X 5 fractions) will be administered over 2 weeks from day 2 to day 16 of the study. Nivolumab (480 mg) will be administered intravenously over 30 minutes every 4 weeks starting on day 17 of the study and continuing until disease progression, unacceptable toxicity, or up to 12 months in patients without disease progression.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 30 days after the last dose of nivolumab, up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-

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By research site
Houston Methodist Hospital· Houston, TX

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