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Renal Cell Carcinoma - C 004

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.

Pending Site Selection

1. UCM301 “Multicenter Phase 3 to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy Treatment of Upper Tract Urothelial Cancer; ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Trial” N= 70 (Sponsor: Steba Biotech UCM301) SUO-CTC PI – Jonathan Coleman, MD, Memorial Sloan Kettering Cancer Center, New York, NY

Open to Patient Accrual

1. CMN-001 “A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma” N= 135 (Sponsor: CoImmune) SUO-CTC PI – Gennady Bratslavsky, MD, SUNY Upstate, Syracuse, NY

Site Locations:
  • MD Anderson
  • Fox Chase Cancer Center
  • H. Lee Moffitt Cancer Center
  • Emory
  • Mayo Clinic - Rochester
  • Houston Methodist Hospital
  • Westchester Medical Center
  • University of Kansas Cancer Center
  • SUNY Upstate
  • Oregon Health Sciences University

Closed/Completed Accrual

1. EA8143 PROSPER RCC “A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy” N= 805 patients (Sponsor: ECOG-ACRIN) SUO-CTC PI – Gennady Bratslavsky, MD and Viraj Master, MD

Site Locations:
  • Albany Medical Center
  • Beth Israel Deaconess Medical Center
  • Cedars-Sinai Medical Center
  • Dana-Farber/Harvard Cancer Center
  • Duke University Medical Center
  • East Jefferson General Hospital
  • Emory University Hospital/Winship Cancer Institute
  • Fox Chase Cancer Center
  • Geisinger Medical Center
  • George Washington University Medical Center
  • Hackensack University Medical Center
  • Henry Ford Hospital
  • Huntsman Cancer Institute/University of Utah
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Kaiser Permanente-Anaheim
  • Kaiser Permanente-Fontana
  • Kaiser Permanente-Oakland
  • Lahey Hospital and Medical Center
  • Lakeland Regional Health Hollis Cancer Center
  • Lexington Medical Center
  • Loyola University Medical Center
  • LSU Healthcare Network / Metairie Multi-Specialty Clinic
  • Maine Medical Partners — South Portland
  • Massachusetts General Hospital Cancer Center
  • Mayo Clinic
  • Medical College of Wisconsin
  • Montefiore Medical Center — Moses Campus
  • Northwestern University
  • NYP/Weill Cornell Medical Center
  • Oregon Health and Science University
  • Parkview Regional Medical Center
  • Penn State Milton S Hershey Medical Center
  • Prisma Health Cancer Institute — Eastside
  • Rambam Medical Center
  • Rush University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • State University of New York Upstate Medical University
  • Tulane University Health Sciences Center
  • UC San Diego Moores Cancer Center
  • UCLA / Jonsson Comprehensive Cancer Center
  • UMass Memorial Medical Center — University Campus
  • UNC Lineberger Comprehensive Cancer Center
  • University of Alambama at Birmingham Cancer Center
  • University of Arizona Cancer Center-North Campus
  • University of California Davis Comprehensive Cancer Center
  • University of Chicago Comprehensive Cancer Center
  • University of Cincinnati/Barrett Cancer Center
  • University of Colorado Hospital
  • University of Florida Health Science Center — Gainesville
  • University of Kansas Cancer Center
  • University of Kansas Hospital-Westwood Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • University of Missouri — Ellis Fischel
  • University of Oklahoma Health Sciences Center
  • University of Pennsylvania/Abramson Cancer Center
  • University of Rochester
  • University of Texas Health Science Center at San Antonio
  • University of Vermont and State Agricultural College
  • University of Vermont Medical Center
  • University of Virginia Cancer Center
  • University of Wisconsin Hospital and Clinics
  • UT Southwestern Clinical Center at Richardson/Plano
  • UT Southwestern/Simmons Cancer Center-Dallas
  • UT Southwestern/Simmons Cancer Center-Fort Worth
  • Vanderbilt University/Ingram Cancer Center
  • Wake Forest University Health Sciences
  • Wayne State University/Karmanos Cancer Institute
  • William Beaumont Hospital — Troy
  • William Beaumont Hospital — Royal Oak
  • Yale University

Closed/Completed Accrual

2. IMmotion010 “A Phase III, Multicenter, Randomized, Placebo-controlled, Double Blind Study of ATEZOLIZUMAB (Anti PD-L1 Antibody) as Adjuvant Therapy in Patients with PD-L1 Selected Renal cell carcinoma at intermediate to high risk of developing metastasis following nephrectomy” N= 1000 global accrual (Sponsor: Genentech/Roche) SUO-CTC PI – Monty Pal MD, City of Hope, Duarte CA and Rob Uzzo MD, Fox Chase Cancer Center, Philadelphia PA

Site Locations:
  • Banner MD Anderson Cancer Center
  • Carolina Urologic Research Center
  • Chesapeake Urology Research Associates
  • City of Hope National Medical Center (Main)
  • City of Hope National Medical Center (Satellite)
  • Cleveland Clinic Foundation
  • Columbia University Medical Center
  • Emory University Winship Cancer Center
  • Erlanger Health Systems
  • Fox Chase Cancer Center
  • Garden State Urology
  • Levine Cancer Institute
  • Loyola University Medical Center
  • Mayo Clinic — Rochester
  • Mayo Clinic — Scottsdale
  • MD Anderson Cancer Center
  • Moffitt Cancer Center
  • Moores Cancer Center at UC San Diego Health
  • Mount Sinai Medical Center
  • NYU Langone Medical Center
  • Ochsner Clinic
  • Oregon Health and Science University
  • Penn State Hershey Cancer Institute
  • Stony Brook University Medical Center
  • SUNY Upstate Medical University
  • The Urological Institute of N.E. New York
  • The Urology Center of Colorado
  • Tulane University
  • UCLA
  • University of California Irvine Medical Center
  • University of Chicago
  • University of Colorado
  • University of Florida
  • University of Miami
  • University of North Carolina
  • University of Oklahoma
  • University of Rochester Medical Center
  • University of Texas Southwestern
  • University of Utah; Huntsman Cancer Hospital
  • UPMC Cancer Centers
  • Urology Associates of Kingsport, P.C.
  • Vanderbilt University Medical Center
  • West Virginia University Hospitals Inc.
  • Yale School of Medicine

Closed/Completed Accrual

3. AGS 003-007 “An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)” N= 450 global accrual (Sponsor: Argos Therapeutics) SUO-CTC PI – Brian Lane MD, Spectrum Health, and Rob Uzzo MD, Fox Chase Cancer Center, Philadelphia PA

SUO-CTC contribution:

  • 38% of Active Sites (50/130)
  • 62% of Tumor Collections (N=712/1133)
  • 61% of Patients Randomized to Treatment (N=284/462)
    • 98% (49) of sites have contributed at least two nephrectomies
    • 96% (48) have randomized at least one patient to therapy
  • Patient Accrual January 2013 thru July 2015
  • Multiple abstracts accepted for presentation

Closed/Completed Accrual

4. “Sunitinib Treatment of Renal Adjuvant Cancer(S-TRAC): A Randomized Double-Blind Phase3 Study of Adjuvant Sunitinib vs. Placebo in Subjects at High Risk of Recurrent RCC – S-TRAC” N= 720 global accrual (Sponsor: Pfizer)

SUO-CTC was a late entry to the project to add to accrual:

  • 5 SUO-CTC sites
  • 10 patients accrued
  • Patient accrual June 2010 thru February 2011