CA209-7G8/ONO-4538-110:A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

Hirashima Yoshinori0 个研究点目标入组 46 人开始时间: 2021年5月28日最近更新: 2023年10月17日

试验速览

暂无简介。

•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

发起方

Hirashima Yoshinori