Bladder Cancer Clinical Trial
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
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 observation for the treatment of participants with IR-NMIBC.
Full Description
Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation 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, complete bladder visualization (e.g., 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.
Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 12 weeks 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 12 weeks 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., Ad-interferon or Adstiladrin)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 10 Locations for this study
Tucson Arizona, 85745, United States More Info
Contact
Principal Investigator
Bakersfield California, 93301, United States More Info
Contact
Principal Investigator
Los Angeles California, 90048, United States More Info
Contact
Principal Investigator
Lakeland Florida, 33805, United States More Info
Contact
Principal Investigator
Baltimore Maryland, 21204, United States More Info
Contact
Principal Investigator
Bronx New York, 10461, United States More Info
Contact
Principal Investigator
Philadelphia Pennsylvania, 19104, United States More Info
Contact
Principal Investigator
Myrtle Beach South Carolina, 29572, United States More Info
Contact
Principal Investigator
Nashville Tennessee, 37209, United States More Info
Contact
Principal Investigator
Austin Texas, 78745, United States More Info
Contact
Principal Investigator
How clear is this clinincal trial information?