Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02798406 : Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- 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

- Tumor recurrence or progression documented after previously failing surgical
resection, chemotherapy and/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

Exclusion Criteria:

- 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 treatment with high-dose systemic corticosteroids within 2 weeks of the start
of intravenous pembrolizumab infusions

- Uncontrolled blood-sugar levels defined as HbA1c > 7% on 2 separate measurements

- Previous treatment with anti-PD1 or PD-L1 agents including pembrolizumab (KEYTRUDA) or
any other checkpoint inhibitor(s) (e.g., ipilimumab, nivolumab, etc.)

- Evidence of active, non-infectious pneumonitis 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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02798406      |      Link to official Clinicaltrials.gov listing
Locations
Toronto, Ontario
Canada

Facility: University Health Network
Investigator: Gelareh Zadeh, MD, PhD
Contact: Takyee Tung Phone: 416-603-5800
Click HERE to send email to this center

Little Rock, Arkansas
Facility: University of Arkansas for Medical Sciences (UAMS)
Investigator: Shirley S Ong, MD
Contact: Candi Langmaid Phone: 501-686-8274
Click HERE to send email to this center

Los Angeles, California
Facility: UCLA Medical Center
Investigator: Timothy Cloughesy, MD
Contact: Emese Filka Phone: 310-794-3521
Click HERE to send email to this center

New Brunswick, New Jersey
Facility: Rutgers Cancer Institute of New Jersey
Investigator: Robert D Aiken, MD
Contact: Celeste Jackson, B.S. Phone: 732-235-9427
Click HERE to send email to this center

New York, New York
Facility: Memorial Sloan Kettering Cancer Center
Investigator:
Contact: Mariza Daras (Brain Tumor Line), MD Phone: 212-639-6767
Email not avaialable

New York, New York
Facility: Weill-Cornell Medicine New York-Presbyterian
Investigator: Rohan Ramakrishna, MD
Contact: Alyson Hignight Phone: 212-746-1788
Click HERE to send email to this center

Cleveland, Ohio
Facility: Cleveland Clinic
Investigator: Michael Vogelbaum, MD, PhD
Contact: Cathy Schilero Phone: 216-636-9410
Click HERE to send email to this center

Columbus, Ohio
Facility: Ohio State University James Cancer Center
Investigator: Vinay Puduvalli, MBBS
Contact: Nadia Osman Phone: 614-685-2435
Click HERE to send email to this center

Allentown, Pennsylvania
Facility: Lehigh Valley Health Network
Investigator: Suresh Nair, MD
Contact: Yasmin Candelo, RN, BSN Phone: 610-402-0636
Click HERE to send email to this center

Austin, Texas
Facility: Texas Oncology Austin-Midtown
Investigator: Morris Groves, MD
Contact: Kristen K Brueggemann, RN, BSN Phone: 512-421-4108
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Houston, Texas
Facility: MD Anderson Cancer Center
Investigator: Fred F Lang, MD
Contact: Sharon Ji, MD, MS Phone: 713-792-2400
Click HERE to send email to this center

Salt Lake City, Utah
Facility: Huntsman Cancer Institute
Investigator: Howard Colman, MD, PhD
Contact: Karthik Sonty Phone: 801-587-5562
Click HERE to send email to this center




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