2024-510976-19-00招募中3 期
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination with Standard of Care Chemotherapy and Durvalumab in Combination with Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients with Unresectable Locally Advanced or Metastatic Urothelial Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 353
- 试验地点
- 43
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To assess the efficacy of durvalumab + SoC combination therapy versus SoC in terms of OS in patients with unresectable locally advanced or metastatic UC and high PD-L1 expression.
To assess the efficacy of Durvalumab and Tremelimumab + SoC combination therapy versus SoC in terms of OS in patients with unresectable locally advanced or metastatic UC and high PD-L1 expression.
研究设计
- 分配方式
- Randomized
- 主要目的
- Post-treatment follow up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)
- •Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred >12 months from the last therapy [for chemoradiation and adjuvant treatment] or >12 months from the last surgery [for neoadjuvant treatment].
- •At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.
- •World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
- •Adequate organ and marrow function as defined in the protocol
- •Life expectancy ≥12 weeks in the opinion of the investigator
- •Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
排除标准
- •Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
- •No severe concomitant condition that requires immunosuppression medication
- •Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Patients who may be eligible for or are being considered for radical resection during the course of the study.
- •Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Progression Free Survival (PFS) - Overall Survival (OS) - Alive and Progression Free Patients at 12 Months (APF12) - Overall Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DoR) - Time from Randomization to Second Progression PFS (PFS2) - Safety - Disease related symptoms
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (43)
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