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

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

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

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 12 weeks 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., Ad-interferon or Adstiladrin)

Study Location

McGill University Health Center - Montreal General Hospital
McGill University Health Center - Montreal General Hospital
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Rodrigo Skowronski

Vancouver Prostate Centre
Vancouver Prostate Centre
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Jonathan Ma

Study Sponsored By
CG Oncology, Inc.
Participants Required
More Information
Study ID: NCT06111235