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)
Condition: Non Muscle Invasive Bladder Cancer, Urologic Cancer, Bladder Cancer, Urothelial Carcinoma
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT06111235
Sponsor: CG Oncology, Inc.
Phase: Phase 3
Eligibility:
- Age: minimum 18 Years maximum N/A
- 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 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)
View trial on ClinicalTrials.gov