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

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Phase 2 Interventional CG Oncology, Inc. · NCT06567743

This study tests a new treatment for people with high-risk non-muscle-invasive bladder cancer to see if it works better than current options.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment325 (estimated)
Ages18 Years and up
SexAll
SponsorCG Oncology, Inc. Industry-sponsored
Locations65 sites (Phoenix, Arizona and 64 other locations)
Trial IDNCT06567743 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with pathologically confirmed high-risk high-grade NMIBC, either BCG-naïve or previously treated with BCG.

Not a fit: Patients with low-risk NMIBC or those who have not been diagnosed with high-grade disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with high-risk NMIBC who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Phoenix, Arizona and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions High-Risk Non-Muscle-Invasive Bladder CancerBladder Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.