CA209-7G8/ONO-4538-110:Phase 3

JRCT ID: jRCT2031210118

Registered date:28/05/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BC
• Date of first enrollment: 15/01/2020
• Target sample size: 46
• Countries of recruitment: USA,Japan,Spain,Japan,UK,Japan,France,Japan,Canada,Japan,Argentina,Japan,Romania,Japan,Netherlands,Japan,Italy,Japan,Australia,Japan,Germany,Japan,Brazil,Japan,Chile,Japan,Greece,Japan,Sweden,Japan,Austria,Japan,Israel,Japan,Ireland,Japan,Russian Federation,Japan,China,Japan
• Study type: Interventional

Intervention(s)

Drug: nivolumab or placebo
Biological: Bacillus Calmette-Guerin (BCG)

Outcome(s)

• Primary Outcome: Event Free Survival (EFS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Hirashima Yoshinori
• Secondary ID(s): NCT04149574