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Bladder Cancer Studies

This section provides a listing of all trials that have been conducted within the SUO-CTC including trials that are in process for site selection, active patient recruitment, or closed to patient accrual.

Open to Patient Accrual

1. “Protocol CA209274: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma” N= 640 global accrual (Sponsor: Bristol Myers Squibb) SUO-CTC PI – Matt Galsky MD, Mount Sinai Medical Center NY, NY

Site Locations:
  • Alaska Clinical Research Center
  • CA and Hematology Centers of W. Michigan
  • Erlanger/University of Tennessee
  • Fairview Health Services (MN)
  • H. Lee Moffitt Cancer Center (FL)
  • Mayo Clinic (MN)
  • Mt. Sinai, NY
  • Oregon Health & Science
  • Roswell Park Cancer Institute (NY)
  • Tulane University Medical Center
  • UF — Gainesville
  • UNC — Chapel Hill
  • University of Pittsburgh
  • US Oncology — Urology Center of CO
  • Winthrop University Hospital (NY)

Pending Site Selection

1. “Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with FGFR3 Genomic Alterations” N= 218 (Sponsor: QED Therapeutics) SUO-CTC PI – Siamak Daneshmand, MD, USC Keck School of Medicine, Los Angeles, CA

Closed/Completed Accrual

1. HS410-101 “A Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response and Clinical Activity of HS-410 in Patients with Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)” N= 100 (Sponsor: Heat Biologics) SUO-CTC PI – Larry Karsh MD, The Urologic Center of Colorado, Denver CO

SUO-CTC Contribution:

  • 89% (17/19) of Active Sites
  • 91% (95/104) of Patients Enrolled
  • Patient Accrual February 2014 thru July 2015

Closed/Completed Accrual

2. “A Phase II, Randomized, Open Label, Parallel Arm Study to Evaluate the Safety and Efficacy of rAd-IFN/Syn3 Following Intravesical Administration in Subjects with High Grade, BCG Refractory, Relapsed or Resistant Non-Muscle Invasive Bladder Cancer (NMIBC)” N= 40 (Sponsor: FKD Therapies) SUO-CTC PI – Colin Dinney MD, MD Anderson Cancer Center, Houston TX

SUO-CTC was the only contributor to this protocol

  • Accrual = 43 patients from 15 sites
  • Average 2.6 patients per month
  • Patient Accrual December 2012 thru February 2014
  • Multiple abstracts accepted for presentation
  • Manuscript in development

Open to Patient Accrual

3. “A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN┬« (rAd-IFN/Syn3) Administered Intravesically to Patients with High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)” N= 130 (Sponsor: FKD Therapies) SUO-CTC PI – Stephen Boorjian MD, Mayo Clinic, Rochester MN

Site Locations:
  • Banner MD Anderson Cancer Center
  • Baylor College of Medicine Medical Center — Urology Clinic
  • Carolina Urologic Research Center
  • Delaware Valley Urology, LLC
  • Duke University Medical Center
  • Emory University Hospital
  • Greenville Hospital System — Cancer Centers of the Carolinas
  • Johns Hopkins Kimmel Cancer Center
  • Mayo Clinic — Rochester
  • MD Anderson Cancer Center
  • Moffitt Cancer Center
  • Ochsner Clinic Foundation
  • Spectrum Health Medical Group
  • SUNY Upstate Medical University
  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
  • The Urology Center of Colorado
  • Thomas Jefferson University
  • University of Chicago
  • University of Florida - Gainesville
  • University of Michigan
  • University of Minnesota
  • University of North Carolina (UNC) — Chapel Hill
  • University of Oklahoma — Health Sciences Center
  • University of Pennsylvania
  • University of Southern California
  • University of Texas Health Science Center at San Antonio
  • University of Texas Southwestern Medical Center
  • University of Virginia Health System
  • University of Wisconsin — Madison
  • Urology of Virginia
  • Washington University
  • West Virginia University Cancer Institute

Open to Patient Accrual

4. IMvigor010 “A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) versus Observation as Adjuvant Therapy in Patients with High Risk Muscle-Invasive Urothelial Carcinoma after Surgical Resection” N= 700 global accrual; US = 150 (Sponsor: Genentech) SUO-CTC PI – Brant Inman MD, Duke University Medical Center, Durham NC

Site Locations:
  • Abramson Cancer Center; Univ of Pennsylvania
  • Baylor College of Medicine
  • Cleveland Clinic
  • Columbia University Medical Center
  • Dana Farber Cancer Institute
  • Duke Cancer Center
  • Fox Chase-Temple Cancer Center
  • Indiana University
  • John Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Karmanos Cancer Institute
  • Kimmel Cancer Center Thomas Jefferson University
  • Levine Cancer Institute
  • Massachusetts General Hospital.
  • Memorial Sloan-Kettering Cancer Center
  • Northwestern University Feinberg School Of Medicine
  • NYU Langone Medical Center
  • Penn State Milton S. Hershey Medical Center
  • Seattle Cancer Care Alliance
  • Stanford University Medical Center
  • The Ohio State University Wexner Medical Center
  • The Urology Center of Colorado 
  • UCLA
  • University of Chicago
  • University Of Colorado
  • University of Iowa Hospital & Clinic
  • University Of Miami Hospital
  • University Of Michigan
  • University of Minnesota
  • University of Texas Health Science Center at San Antonio
  • University of Texas Southwestern
  • University of Virginia
  • USC Norris Cancer Center
  • Wake Forest University Baptist Medical Center
  • Yale Medical Center

Early Termination

1. “Efficacy and Safety Evaluation of EN3348 (MCC) as compared with Mitomycin C in the Intravesical Treatment of Subjects with BCG Recurrent/Refractory Non-muscle invasive Bladder Cancer EN3348-303” N= 60 global accrual (Sponsor: Endo Pharmaceuticals)

Early Termination

2. “A Phase 3B, Randomized, Open-Label, Multi Center Study to Evaluate the Efficacy and Safety of Maintenance Therapy with Valrubicin versus No Maintenance, in Subjects Treated with Valrubicin Induction for Carcinoma In Situ (CIS) of the Bladder EN3329-301” N= 60 (Sponsor: Endo Pharmaceuticals)

Early Termination

3. CBC 819-18-204 “A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin” N= 140 from 50 sites (Sponsor: Anchiano Therapeutics)