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.
Brief Title
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
949-409-3700
Central Contact Email
Recruitment@cgoncology.com
Central Contact Role
Contact
Central Contact Phone
949-409-3700
Central Contact Email
medicalaffairs@cgoncology.com
Completion Date
Completion Date Type
Estimated
Conditions
Non Muscle Invasive Bladder Cancer
Urologic Cancer
Bladder Cancer
Urothelial Carcinoma
Eligibility 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 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)
* 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)
Inclusion 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 90 days of study randomization
* Acceptable baseline organ function
* 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
Gender
All
Gender Based
false
Keywords
Urology
Bladder Cancer
Non Muscle Invasive Bladder Cancer
Intermediate Risk Non Muscle Invasive Bladder Cancer
Cretostimogene Grenadenorepvec
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06111235
Org Class
Industry
Org Full Name
CG Oncology, Inc.
Org Study Id
PIVOT-006
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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)
Primary Outcomes
Outcome Description
Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT
Outcome Measure
Recurrence Free Survival (RFS)
Outcome Time Frame
51 months
Secondary Outcomes
Outcome Description
Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT at 12 months and 24 months
Outcome Time Frame
51 months (RFS at 12 months) and 63 months (RFS at 24 months)
Outcome Measure
Recurrence Free Survival (RFS) at 12 months and 24 months
Outcome Description
Safety of cretostimogene following TURBT
Outcome Time Frame
52 months
Outcome Measure
Incidence of Adverse Events
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alexander Sankin
Investigator Email
asankin@montefiore.org