A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
PIVOT-006 (primary)
NCI-2024-03570
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.
Objectives
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.
Eligibility
- Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
- Recurrent LG Ta within 12 months of prior LG or HG (HG Ta = 3 cm) tumor
- Solitary LG Ta >3 cm tumor
- Multifocal LG Ta tumors
- Primary and solitary HG Ta =3 cm tumor
- LG T1 tumor
- All visible disease removed by TURBT within 90 days of study randomization
- Acceptable baseline organ function
Treatment Sites in Georgia
230 East DeRenne Ave
Savannah, GA 31405
(912) 790-4036
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.