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

NCT02831933 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-09-21

Study results available
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Summary

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.

Conditions

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

Interventions

BIOLOGICAL

ADV/HSV-tk

Replication-defective recombinant adenovirus vector

DRUG

Valacyclovir

Prodrug of the antiviral drug acyclovir

RADIATION

SBRT

Low-dose SBRT

DRUG

nivolumab

Fully human immunoglobulin (Ig) G4 anti-PD-1 monoclonal antibody

Sponsors & Collaborators

  • Eric Bernicker, MD

    lead OTHER

Principal Investigators

  • Eric Bernicker, M.D. · 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
2017-02-15
Primary Completion
2020-11-05
Completion
2020-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02831933 on ClinicalTrials.gov