A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem/Cis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 150
- 试验地点
- 90
- 主要终点
- The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
研究概览
简要总结
The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology
- •Patients must be planning to undergo radical cystectomy
- •Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer
- •ECOG performance status of 0 or 1
- •Minimum life expectancy of 12 weeks at first dose of study medication
排除标准
- •Evidence of lymph node (N2-N3) or metastatic (M1) disease
- •Inoperable tumour(s) with fixation to the pelvic wall on clinical examination
- •Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
- •Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem/cis).
- •Uncontrolled intercurrent illness.
研究组 & 干预措施
gem/cis cohort
Durvalumab + chemotherapy
干预措施: Gemcitabine (Drug)
gem/cis cohort
Durvalumab + chemotherapy
干预措施: Cisplatin (Drug)
ddMVAC cohort
Durvalumab + chemotherapy
干预措施: Durvalumab (Drug)
ddMVAC cohort
Durvalumab + chemotherapy
干预措施: Doxorubicin (Drug)
ddMVAC cohort
Durvalumab + chemotherapy
干预措施: Cisplatin (Drug)
ddMVAC cohort
Durvalumab + chemotherapy
干预措施: Vinblastine (Drug)
gem/cis cohort
Durvalumab + chemotherapy
干预措施: Durvalumab (Drug)
ddMVAC cohort
Durvalumab + chemotherapy
干预措施: Methotrexate (Drug)
结局指标
主要结局
The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
时间窗: Up to 6 months
Incidence of Grade 3 or 4 \[possibly treatment-related adverse events (PRAEs)\] as observed prior to RC.
次要结局
- The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis.(Up to 2 years)
- The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS).(Up to 3 years)
- The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS).(Up to 3 years)
- The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS.(Up to 3 years)
- The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic complete response (pCR).(Up to 3 years)
- The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic downstaging (pDS).(Up to 3 years)