Trials / Active Not Recruiting
Active Not RecruitingNCT06111235
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 367 (actual)
- Sponsor
- CG Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cretostimogene Grenadenorepvec | Engineered Oncolytic Adenovirus |
| OTHER | n-dodecyl-B-D-maltoside | Transduction-enhancing agent |
Timeline
- Start date
- 2023-12-14
- Primary completion
- 2026-06-01
- Completion
- 2029-02-01
- First posted
- 2023-11-01
- Last updated
- 2026-01-12
Locations
95 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06111235. Inclusion in this directory is not an endorsement.