NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210118

Registered date:28/05/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedHigh-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BC
Date of first enrollment15/01/2020
Target sample size46
Countries of recruitmentUSA,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 typeInterventional
Intervention(s)Drug: nivolumab or placebo Biological: Bacillus Calmette-Guerin (BCG)

Outcome(s)

Primary OutcomeEvent Free Survival (EFS)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Center Information Medical
Address 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan Osaka Japan 618-8585
Telephone +81-120-626-190
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD
Scientific contact
Name Yoshinori Hirashima
Address 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan Osaka Japan 618-8585
Telephone +81-120-626-190
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD