UPCC 04824 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)

Study of Investigational Treatment versus Observation for Intermediate Risk Bladder Cancer

Enrolling By Invitation
18 years or above
All
Phase 3
367 participants needed
1 Location

Brief description of study

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

Detailed description of study

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs surveillance 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, 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. CT Urogram/MRU every 12 months.

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

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non Muscle Invasive Bladder Cancer, Urologic Cancer, Bladder Cancer, Urothelial Carcinoma
  • Age: 18 years or above
  • Gender: All

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 90 days 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., Adstiladrin)

This study investigates the effectiveness of an investigational medication compared to observation in treating intermediate risk non-muscle invasive bladder cancer (IR-NMIBC). The purpose of this study is to see if the investigational medication can help prevent the cancer from returning after the initial surgical removal of the tumor.

Participants in the study will undergo a transurethral resection of the bladder tumor (TURBT), a procedure to remove the visible cancer. Those in the investigational arm will receive the medication after the surgery and continue with maintenance doses every three months up to 13 months, provided there is no recurrence of the disease. All participants will have regular assessments, including urine tests, bladder examinations, and imaging, to monitor their disease status.

  • Who can participate: Participants must have intermediate risk non-muscle invasive bladder cancer confirmed by guidelines and have had all visible disease removed by TURBT within 90 days before joining the study. They must also have acceptable baseline organ function. Those with high-risk or low-risk bladder cancer, disease in the prostatic urethra, or prior treatment with certain adenovirus-based therapies are excluded.
  • Study details: Participants will either receive the investigational medication after surgery or be under observation. If cancer returns, those in the observation group can receive the investigational treatment. The medication is given in an induction course followed by quarterly maintenance.
Updated on 01 Jul 2026. Study ID: 24-0177
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