Evaluating a new treatment for high-risk non-muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study assesses the safety and efficacy of Cretostimogene Grenadenorepvec in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). Participants are divided into multiple cohorts based on their treatment history with Bacillus Calmette-Guerin (BCG) and the specific characteristics of their cancer. The study involves randomizing participants to receive the treatment through different instillation procedures. The goal is to determine how well this new therapy works compared to existing options.

Why it matters

Who can join: the full rules

Cohort A Key Inclusion Criteria:

* Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
* Acceptable baseline organ function.

Cohort B Key Inclusion Criteria:

* Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
* Acceptable baseline organ function.

Cohort CX Inclusion Criteria

* Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
* Acceptable baseline organ function.

Key Exclusion Criteria (Both Cohorts):

* Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
* High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract.
* Significant immunodeficiency.
* Pregnant or breastfeeding.
* Cohort CX Only: serial intravesical gemcitabine within 24 months

Where it's running

• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Arkansas Urology
  Little Rock, Arkansas, United States Recruiting
• Michael G Oefelein, MD Clinical Trials
  Bakersfield, California, United States Recruiting
• City of Hope
  Irvine, California, United States Recruiting

+30 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Rebecca Tregunna, MD
• Email: Rebecca.Tregunna@cgoncology.com
• Phone: 949 409-3700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

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• JL19001 Injection for High-Risk NMIBC (alone or with BCG)

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• HS-10566 treatment in high-risk non-muscle-invasive bladder cancer where surgery isn’t an option

  This study tests HS-10566 to see if it can help people with high-risk NMIBC who can’t or won’t have radical cystectomy.

  Recruiting at 2 sites Phase 1/2 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07468851

• Evaluating a new treatment for high-risk bladder cancer that expresses HER2

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• Treatment of intermediate and high-risk non-muscle invasive bladder cancer with SHR-2005

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  Recruiting Phase 1 Shanghai Hengrui Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality · NCT06108492

• MRI (VI-RADS) plus photodynamic-guided TURBT to avoid routine repeat bladder resections

  This study tests whether using a preoperative MRI VI-RADS score together with photodynamic-assisted TURBT can let people with non-muscle-invasive bladder cancer safely skip a routine second resection.

  Recruiting Phase 4 University of Roma La Sapienza · Rome, Lazio · NCT05962541

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.