Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects

Completed · Phase 2

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

In brief

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

Key facts

Study ID

NCT02798406

Run by

DNAtrix, Inc.

People needed

49

Starts

2016-10-06

Expected to finish

2021-06-30

Last updated by the study team

2021-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A single glioblastoma or gliosarcoma tumor with histopathological confirmation for first or presenting second recurrence of glioblastoma or gliosarcoma at the time of consent
• Gross total or partial tumor resection is not possible or not planned
• A single measurable tumor that is at least 10.0 mm longest diameter (LDi) X 10.0 mm shortest diameter (SDi) and this tumor does not exceed 40.0 mm in LDi or SDi on Screening MRI
• Tumor recurrence or progression documented after previously failing surgical resection, chemotherapy or radiation
• Karnofsky performance status ≥ 70 %
• Prior anti-tumor therapies must have been completed within time periods specified in the protocol prior to DNX-2401 injection and toxic side effects must be mild, if present
• Demonstrate adequate organ function via specified laboratory test results

You may not qualify if…

• Multiple (≥ 2) separate enhancing tumors
• Tumor location on both sides of the brain and/or involvement that would present the risk of injecting DNX-2401 into the ventricles of the brain
• Tumor location in the brain stem
• Requires or, based upon history, may require treatment with high-dose systemic corticosteroids within 2 weeks of the start of intravenous pembrolizumab infusions and within 2 weeks following the first infusion of pembrolizumab
• Uncontrolled blood-sugar levels defined as HbA1c > 7%
• Previous treatment with any checkpoint inhibitor such as anti-PD1 or PD-L1 agents including pembrolizumab (KEYTRUDA) or any other checkpoint inhibitor(s) (e.g., ipilimumab, nivolumab, etc.)
• History of (non-infectious) or current active pneumonitis that required steroids and/or a history of interstitial lung disease
• Prior gene transfer therapy or prior therapy with a cytolytic virus of any type
• Brain tumor that is not measurable on MRI or persons who are unable to have MRIs
• Pregnant or nursing females
• Note: Other protocol-defined inclusion and exclusion criteria may apply as outlined in the relevant protocol version

Where it is running

• University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States
• UCLA Medical Center — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Minnesota Neurosurgery — Minneapolis, Minnesota, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill-Cornell Medicine New York-Presbyterian — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University James Cancer Center — Columbus, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Texas Oncology Austin-Midtown — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University Health Network — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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