CA209-7G8/ONO-4538-110:Phase 3
- Conditions
- High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BC
- Registration Number
- JPRN-jRCT2031210118
- Lead Sponsor
- Hirashima Yoshinori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
1. Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
2. Persistent or recurrent disease <= months of last BCG dose, but not classified as BCG unresponsive
3. Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)
4. Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)
5. Sufficient tissue for both biomarker analysis and central pathology review committee (PRC) confirmation of diagnosis
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
7. Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to follow contraceptive requirements
1. Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC
2. UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
3. UC and/or CIS in the prostatic urethra within 12 months of enrollment
4. Prior surgery (other than transurethral resection of the bladder tumor (TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic chemotherapy or immunotherapy for bladder cancer or UC
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method