MedTrace Logo

Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects

NCT02798406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-07-15

No results posted yet for this study

Summary

Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase II study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified oncolytic adenovirus, when delivered directly into the tumor followed by the administration of intravenous pembrolizumab (an immune checkpoint inhibitor) given every 3 weeks for up to 2 years or until disease progression.

Funding Source-FDA OOPD

Conditions

  • Brain Cancer
  • Brain Neoplasm
  • Glioma
  • Glioblastoma
  • Gliosarcoma
  • Malignant Brain Tumor
  • Neoplasm, Neuroepithelial
  • Neuroectodermal Tumors
  • Neoplasm by Histologic Type
  • Neoplasm, Nerve Tissue
  • Nervous System Diseases

Interventions

BIOLOGICAL

DNX-2401

On Day 0, following brain tumor biopsy and confirmation of recurrent tumor, a single injection of DNX-2401 is administered directly into the brain tumor.

BIOLOGICAL

pembrolizumab

Sequential intravenous administration every three weeks beginning 7-9 days after Day 0/DNX-2401

Sponsors & Collaborators

Principal Investigators

  • Nancy Gady, BS · DNAtrix, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2021-03-17
Completion
2021-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02798406 on ClinicalTrials.gov