Last updated on May 2018

A Study to Evaluate INSTILADRIN in Patients With High-Grade Bacillus Calmette-Guerin (BCG) Unresponsive NMIBC


Brief description of study

Previous multi-dose Phase I and Phase II clinical studies have demonstrated that INSTILADRIN (nadofaragene firadenovec) is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of INSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.

Detailed Study Description

Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in Non-Muscle Invasive Bladder Cancer (NMIBC). INSTILADRIN is a non-replicating adenovirus vector harboring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder. The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein. Clinical studies have confirmed that IFN alpha2b protein can be measured in the urine of patients treated with INSTILADRIN within 24 hours after dosing.

Clinical Study Identifier: NCT02773849

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Joseph Mashni, MD

Banner MD Anderson Cancer Center
Gilbert, AZ United States

Anne Schuckman, MD

Keck School of Medicine at USC Medical Center
Los Angeles, CA United States

Lawrence I Karsh, MD

The Urology Center of Colorado
Denver, CO United States

Paul Crispen, MD

University of Florida - UF Health Davis Center Pavilion and Shands Med Plaza
Gainesville, FL United States

Michael Poch, MD

H. Lee Moffitt Cancer Center & Research Institute
Tampa, FL United States

Mehrdad Alemozaffar, MD

Emory University School of Medicine
Atlanta, GA United States

Gary Steinberg, MD

University of Chicago - Section of Urology, MC 6038
Chicago, IL United States

Daniel Canter, MD

Oshner Clinic Foundation
New Orleans, LA United States

Trinity Bivalacqua, MD

Johns Hopkins Kimmel Cancer Center
Baltimore, MD United States

Jeffrey Montgomery, MD

University of Michigan
Ann Arbor, MI United States

Brian Lane, MD

Spectrum Health Medical Group
Grand Rapids, MI United States

Badrinath Konety, MD

University of Minnesota
Minneapolis, MN United States

Stephen Boorjian, MD

Mayo Clinic - Rochester
Rochester, MN United States

Jerry Adriole, MD

Washington University School of Medicine
Saint Louis, MO United States

Gordon Brown, MD

Delaware Valley Urology, LLC
Voorhees, NJ United States

Gennady Bratslavsky, MD

SUNY Upstate Medical Center
Syracuse, NY United States

Michael Woods, MD

University of North Carolina (UNC) - Chapel Hill
Chapel Hill, NC United States

Michael Cookson, MD

The University of Oklahoma Health Sciences Center
Oklahoma City, OK United States

David G Sawutz, PhD

Penn State Milton S. Hershey Medical Center
Hershey, PA United States

Thomas Guzzo, MD

The Hospital of the University of Pennsylvania
Philadelphia, PA United States

Leonard Gomella, MD

Thomas Jefferson University
Philadelphia, PA United States

Erik J Busby, MD

Regional Urology
Greenville, SC United States

Neal Shore, MD

Carolina Urologic research Center
Myrtle Beach, SC United States

Kirk Keegan, MD

Vanderbilt University Medical Center Dept. of Urologic Surgery
Nashville, TN United States

Yair Lotan, MD

University of Texas Southwestern Medical Center
Dallas, TX United States

Seth Lerner, MD

Baylor College of Medicine
Houston, TX United States

Ashish Kamat, MD

MD Anderson Cancer Center
Houston, TX United States

Robert Svatek, MD

The Univ. of Texas Health Science Center at San Antonio
San Antonio, TX United States

Tracey Krupski, MD

University of Virginia Health System
Charlottesville, VA United States

Michael Williams, MD

Urology of Virginia
Virginia Beach, VA United States

Adam Luchey, MD

West Virginia University Cancer Institute
Morgantown, WV United States

Tracy Downs, MD

University of Wisconsin - Madison
Madison, WI United States

Alexander Sankin, MD

Montefiore Medical Center
Bronx, NY United States

Brant Inman, MD

Duke University
Durham, NC United States