Bladder Cancer, Non Muscle Invasive Bladder Cancer, Urologic Cancer, Urothelial Carcinoma
Conditions
Keywords
Urology, Bladder Cancer, Non Muscle Invasive Bladder Cancer, Intermediate Risk Non Muscle Invasive Bladder Cancer, Cretostimogene Grenadenorepvec
Brief 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.
Interventions
Engineered Oncolytic Adenovirus
Transduction-enhancing agent
Sponsors
CG Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by adjuvant cretostimogene versus TURBT alone for the treatment of participants with IR-NMIBC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival (RFS) | 29 months | Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival (RFS) at 6 months, 12 months and 24 months | 27 months (RFS at 6 months), 33 months (RFS at 12 months) and 45 months (RFS at 24 months) | Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT at 12 months and 24 months |
| Incidence of Adverse Events | 34 months | Safety of cretostimogene following TURBT |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORMax Kates, MD
Johns Hopkins University
Outcome results
None listed