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

a study on Bladder Cancer Urologic Cancer Transitional Cell Carcinoma Urinary Bladder Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Edward Uchio, MD

Description

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.

Official Title

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)

Details

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.

Keywords

Non Muscle Invasive Bladder Cancer, Urologic Cancer, Bladder Cancer, Urothelial Carcinoma, Urology, Intermediate Risk Non Muscle Invasive Bladder Cancer, Cretostimogene Grenadenorepvec, Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Urologic Neoplasms, n-dodecyl-B-D-maltoside, Cretostimogene after TURBT

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of California Irvine Medical Center (UCIMC) accepting new patients
    Orange California 92868 United States
  • Sun Kim Urology accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Edward Uchio, MD
    Clinical Professor, Urology, School of Medicine. Authored (or co-authored) 81 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CG Oncology, Inc.
Links
NCCN Guidelines Bladder Cancer 3.2023
ID
NCT06111235
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 364 study participants
Last Updated
Contact us about this trial