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Brief Title: Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

INTRODUCTION

  • Org Study ID: PIVOT-006
  • Secondary ID: N/A
  • NCT ID: NCT06111235
  • Sponsor: CG Oncology, Inc.

DESCRIPTION

The purpose of this study is to see if cretostimogene can reduce the risk of your bladder cancer returning, or coming back as quickly as if you did not receive cretostimogene. People in the study will continue to be monitored by cystoscopy and pathology to see how long it takes for the cancer to return. Cretostimogene is an experimental drug and not all risks are known. It is being studied to determine whether it is effective and safe in the treatment of Non-Muscle Invasive Bladder Cancer.

View the PIVOT-006 website or download this document for more information about this trial. Or for a listing of questions to ask your doctor, click here.

Learn more about the trial by watching this video:

BRIEF SUMMARY

This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC.

DETAILED DESCRIPTION

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation after TURBT (Arm B).

Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.

Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence.

Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

  • Overall Status
    Recruiting
  • Start Date
    December 14, 2023
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recurrence Free Survival (RFS)

Primary Outcome 1 - Timeframe: 51 months

CONDITION

  • Non Muscle Invasive Bladder Cancer
  • Urologic Cancer
  • Bladder Cancer
  • Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
* Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor

- 2. Solitary LG Ta >3 cm tumor

- 3. Multifocal LG Ta tumors

- 4. Primary and solitary HG Ta ≤3 cm tumor

- 5. LG T1 tumor

- * All visible disease removed by TURBT within 12 weeks of study randomization

- * Acceptable baseline organ function
Exclusion Criteria:
* High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)

- * Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)

- * Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization

- * Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer

- * Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Robert Svatek, MD

Role: Principal Investigator

Affiliation: University of Texas Health Science Center, San Antonio

Overall Contact

Name: Shelly Basye, MD, Andy Darilek, MD

Phone: 949-409-3700, 949-409-3700

Email: [email protected], [email protected]

LOCATION

Facility Status Contact
Facility: Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: Contact
Holly Bowen

Principal Investigator
Chinedu Mmeje, MD

Facility: Mayo Clinic
Scottsdale, Arizona 85259
United States
Status: Recruiting Contact: Contact
Kae Kaczmarski

Principal Investigator
Mark Tyson, MD

Facility: Arizona Institute of Urology PLLC
Tucson, Arizona 85745
United States
Status: Recruiting Contact: Contact
Andrea Navarrette

Principal Investigator
Kalpesh Patel, MD

Facility: Arkansas Urology PA
Little Rock, Arkansas 72211
United States
Status: Recruiting Contact: Contact
Katie O'Brien

Principal Investigator
R. Jonathan Henderson, MD

Facility: Michael G. Oefelein MD Clinical Trials
Bakersfield, California 93301-2284
United States
Status: Recruiting Contact: Contact
Evelyn De La Cruz

Principal Investigator
Michael Oefelein, MD

Facility: USC/Keck Department of Urology
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Qingru Feng

Principal Investigator
Anne Schuckman, MD

Facility: Tower Urology
Los Angeles, California 90048
United States
Status: Recruiting Contact: Contact
Shiblee Nomanee

Principal Investigator
David Josephson, MD

Facility: Sun Kim Urology
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Tam Le

Principal Investigator
Sun Kim, MD

Facility: University of California Irvine Medical Center (UCIMC)
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Phillip Duffy

Principal Investigator
Edward Uchio, MD

Facility: University of California Davis Cancer Center
Sacramento, California 95817
United States
Status: Recruiting Contact: Contact
Jasmeet Bhullar

Principal Investigator
Thenappan Chandrasekar, MD

Facility: Stanford University School of Medicine
Stanford, California 94305
United States
Status: Recruiting Contact: Contact
Kristine Talavera
650-723-0525
[email protected]

Principal Investigator
Eila Skinner, MD

Facility: Urology Associates, PC
Lone Tree, Colorado 80124
United States
Status: Recruiting Contact: Contact
Bradley Gord

Principal Investigator
Bradley Bell, MD

Facility: MedStar Washington Hospital Center
Washington, District of Columbia 20010
United States
Status: Recruiting Contact: Contact
Gilbert Horst

Principal Investigator
Lambros Stamatakis, MD

Facility: Advanced Urology Institute
Daytona Beach, Florida 32114
United States
Status: Recruiting Contact: Contact
Sara Esposito
386-236-2676
[email protected]

Principal Investigator
Samuel Lawindy, MD

Facility: Lakeland Regional Health
Lakeland, Florida 33805
United States
Status: Recruiting Contact: Contact
Maczko Bridget

Principal Investigator
Peter Hinds, MD

Facility: Advanced Urology Institute, LLC
Largo, Florida 33771
United States
Status: Recruiting Contact: Contact
Amy Franklin

Principal Investigator
Matthew Truesdale, MD

Facility: Emory Winship Cancer Center
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Sierra Williams
404-712-7854
[email protected]

Principal Investigator
Vikram Narayan, MD

Facility: Velocity Clinical Research- Savanah Urological Associates
Savannah, Georgia 31405
United States
Status: Recruiting Contact: Contact
Jamie Hill

Principal Investigator
Buffi Boyd, MD

Facility: UroPartners LLC
Glenview, Illinois 60026
United States
Status: Recruiting Contact: Contact
Karolina Webb
708-273-3737
[email protected]

Principal Investigator
Jeffrey A Pearl, MD

Facility: Duly Health and Care
Lisle, Illinois 601152
United States
Status: Recruiting Contact: Contact
Theresa Campos

Principal Investigator
Ranko Miocinovic, MD

Facility: Urology of Indiana, LLC
Carmel, Indiana 46032
United States
Status: Recruiting Contact: Contact
Sarah Faisal
315-478-4185
7794
[email protected]

Principal Investigator
Chad Reichard, MD

Facility: Wichita Urology Group
Wichita, Kansas 67226
United States
Status: Recruiting Contact: Contact
Tyler Gentry

Principal Investigator
PHilippe Nabbout, MD

Facility: First Urology, PSC
Louisville, Kentucky 47130
United States
Status: Recruiting Contact: Contact
Samantha Taylor

Principal Investigator
Ryan Malone, MD

Facility: Southern Urology
Lafayette, Louisiana 70508
United States
Status: Recruiting Contact: Contact
Wilson Simmons

Principal Investigator
Jason Bourque, MD

Facility: Regional Urology, LLC
Shreveport, Louisiana 71106
United States
Status: Recruiting Contact: Contact
Kayla Telano

Principal Investigator
David Price, MD

Facility: Chesapeake Urology Associates, LLC
Baltimore, Maryland 21204
United States
Status: Recruiting Contact: Contact
Chastity Berry

Principal Investigator
Rian Dickstein, MD

Facility: Johns Hopkins Hospital Green Spring Station
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Tina Wlajnitz

Principal Investigator
Max Kates, MD

Facility: Michigan Institute of Urology, PC
Troy, Michigan 48084
United States
Status: Recruiting Contact: Contact
Danielle Osterhout

Principal Investigator
Jason Hafron, MD

Facility: Mayo Clinic
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Contact
Katie Barthels

Principal Investigator
Paras Shah, MD

Facility: The Urology Group
Southaven, Mississippi 38671
United States
Status: Recruiting Contact: Contact
Trina Watson

Principal Investigator
Mark Greenberger, MD

Facility: Objective Health - Specialty Clinical Research of St. Louis
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: Contact
Sheila Hamilton

Principal Investigator
Gregory Auffenberg, MD

Facility: Urology Nevada
Reno, Nevada 89511
United States
Status: Recruiting Contact: Contact
Jennifer Becker
775-829-5707
[email protected]

Principal Investigator
Dimitar Zlatev, MD

Facility: Garden State Urology, LLC- Morristown Medical Center
Morristown, New Jersey 07962
United States
Status: Recruiting Contact: Contact
Kathryn Radler

Principal Investigator
Sandip Prasad, MD

Facility: Rutgers Cancer Institute of New Jersey - Cancer Center
New Brunswick, New Jersey 08901
United States
Status: Recruiting Contact: Contact
Alicia Moore

Principal Investigator
Vignesh Packiam, MD

Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Contact
Andrea Asencio

Principal Investigator
Alexander Sankin, MD

Facility: Integrated Medical Professionals PLLC
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Michael Yang

Principal Investigator
Jed Kaminetsky, MD

Facility: NYU Langone Health
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Ari Sysimaki

Principal Investigator
Katie Murray, DO

Facility: Associated Medical Professionals of NY
Syracuse, New York 13202
United States
Status: Recruiting Contact: Contact
Sarah Faisal

Principal Investigator
Christopher Pieczonka, MD

Facility: Urology Group
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: Contact
Julie Sebastian

Principal Investigator
Marc Pliskin, DO

Facility: Oregon Urology Insititute
Springfield, Oregon 97477
United States
Status: Recruiting Contact: Contact
Maxim DiMarco

Principal Investigator
Bryan Mehlhaff, MD

Facility: Midlantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Catherine Frye

Principal Investigator
Laurence Belkoff, DO

Facility: Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Status: Recruiting Contact: Contact
Seyma Demirsoy
717-531-1053
[email protected]

Principal Investigator
Hong Truong, MD

Facility: Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United States
Status: Recruiting Contact: Contact
Kristina Baker

Principal Investigator
Paul Sieber, MD

Facility: University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Dylan Kolman

Principal Investigator
Trinity Bivalacqua, MD

Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Jessica Richardson

Principal Investigator
Neal Shore, MD

Facility: Lowcountry Urology Clinics
North Charleston, South Carolina 29406
United States
Status: Recruiting Contact: Contact
Samara Grimes

Principal Investigator
Justin Ellett, MD

Facility: The Conrad Pearson Clinic
Germantown, Tennessee 38138
United States
Status: Recruiting Contact: Contact
Russell Grigsby

Principal Investigator
Ravi Chauhan, MD

Facility: Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Joe Wallace

Principal Investigator
Gautam Jayram, MD

Facility: Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: Contact
Darlene Hancock

Principal Investigator
Amy Luckenbaugh, MD

Facility: Urology Associates of North Texas
Arlington, Texas 76017
United States
Status: Recruiting Contact: Contact
Grace Yoon

Principal Investigator
Michael Collini, MD

Facility: Urology Austin, PLLC
Austin, Texas 78745
United States
Status: Recruiting Contact: Contact
Cecilia Moreno

Principal Investigator
Brian Mazzarella, MD

Facility: Houston Methodist Research Institute
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Sejal Dave
[email protected]

Principal Investigator
Raj Satkunasivam, MD

Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Marisa Lozano

Principal Investigator
Kelly Bree, MD

Facility: Michael E. DeBakey VA Medical Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Thuy Pham

Principal Investigator
Jennifer Taylor, MD

Facility: Houston Metro Urology
Houston, Texas 77074
United States
Status: Recruiting Contact: Contact
Johanna Villamizar

Principal Investigator
Zvi Schiffman, MD

Facility: Urology San Antonio PA
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Gavon T Payne

Contact
Juliana M Velazquez

Principal Investigator
Daniel Zainfeld, MD

Facility: Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
Virginia Beach, Virginia 23462
United States
Status: Recruiting Contact: Contact
James Knight

Principal Investigator
Michael Williams, MD

Facility: University of Washington Medical Center
Seattle, Washington 98195
United States
Status: Recruiting Contact: Contact
CHORD Research

Principal Investigator
John Gore, MD

Facility: Spokane Urology- Southside
Spokane, Washington 99202
United States
Status: Recruiting Contact: Contact
Amy Bardwell

Principal Investigator
Shane Pearce, MD

Facility: Charleston Area Medical Center
Charleston, West Virginia 25304
United States
Status: Recruiting Contact: Contact
Jordan Campanelli

Principal Investigator
Michael Stencel, DO