EUCTR2018-002676-40-ES进行中（未招募）1 期
A Phase 3, Randomized, Study of Neoadjuvant and AdjuvantNivolumab Plus NKTR-214, Versus Nivolumab Alone VersusStandard of Care in Participants with Muscle-Invasive BladderCancer (MIBC) Who Are Cisplatin Ineligible
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder tumor (TURBT)
- •- Must be deemed eligible for RC by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy.
- •- Eastern Cooperative Oncology Group (ECOG) performance status
- •- Cisplatin-ineligible participants will be defined by any one of the
- •following criteria:
- •i) Impaired renal function (glomerular filtration rate [GFR] = 30 but
- •< 60 mL/min)
- •ii) GFR should be assessed by direct measurement (ie, creatinine
- •clearance) or, if not available, by calculation from serum/plasma
- •creatinine (Cockcroft-Gault formula)
- •iii) Common Terminology Criteria for Adverse Events (CTCAE)
- •version 5, = Grade 2 hearing loss (assessed per local SOC).
- •iv) CTCAE version 5, = Grade 2 peripheral neuropathy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 216
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 504
排除标准
- •- Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer.
- •- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted.
- •Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is
- •permitted if completed at least 6 weeks prior to initiating study treatment.
- •- Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC or urothelial carcinoma not confined to the bladder.
- •Other protocol defined inclusion/exclusion criteria could apply.
研究者
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