A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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)

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

Condition
Non Muscle Invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Scottsdale

Mayo Clinic, Scottsdale, Arizona, United States, 85259

Tucson

Arizona Institute of Urology PLLC, Tucson, Arizona, United States, 85745

Little Rock

Arkansas Urology PA, Little Rock, Arkansas, United States, 72211

Bakersfield

Michael G. Oefelein MD Clinical Trials, Bakersfield, California, United States, 93301-2284

Los Angeles

USC/Keck Department of Urology, Los Angeles, California, United States, 90033

Los Angeles

Tower Urology, Los Angeles, California, United States, 90048

Orange

Sun Kim Urology, Orange, California, United States, 92868

Orange

University of California Irvine Medical Center (UCIMC), Orange, California, United States, 92868

Sacramento

University of California Davis Cancer Center, Sacramento, California, United States, 95817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CG Oncology, Inc.,

Robert Svatek, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center, San Antonio

Study Record Dates

2030-01