An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Trial Status: closed to accrual
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.
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:
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
