Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy: a Phase II, Randomized Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Locoregional control rate
研究概览
简要总结
The purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic MIBC who are not candidates for radical cystectomy
详细描述
The initial hypothesis is that addition of nivolumab will increase 2-year locoregional control rate from 55% (control arm) to 75% (immunotherapy arm)
There is a 24 month accrual period during which 78 patients will be randomized in a control group (standard chemo-radiotherapy) and the treatment group (chemo-radiotherapy + Nivolumab)
The primary objective would be to compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy.
The secondary objectives are
- To study the safety of the addition of nivolumab to chemoradiotherapy in patients with MIBC
- To compare 2-year bladder cancer failure-free (BCFF) rates, defined as distant metastasis free survival (MFS) AND/OR locoregional failure (defined as in primary objective)
- To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
- Assess the effect of combined treatment on the quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically proven, muscle-invasive carcinoma of the bladder, cT2-T4aN0M0
- •Urothelial, squamous or glandular histology according to WHO 2016 classification (Fig 1)
- •Undergone a vigorous TURB
- •Not candidates for radical cystectomy.
- •age >18 years old
- •Adequate bone marrow function
- •Adequate renal function
排除标准
- •Histology other than transitional-cell, squamous or adenocarcinoma
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer cervix or breast.
- •Previous systemic chemotherapy or prior biologic agents within 4 weeks, or intravesical Bacillus Calmette-Guerin (BCG) within 6 weeks of the first dose of study treatment.
- •Prior treatment with any PD-1 or PDL-1 inhibitor or anti CTLA4 agent
- •Previous pelvic radiation therapy.
- •Patients with inherited syndromes associated with hypersensitivity to ionizing radiation
- •Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation
- •Any history of inflammatory bowel disease and or history of abdominal fistula
- •Previous allergy to any of the study drugs
结局指标
主要结局
Locoregional control rate
时间窗: 2 years
To compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
次要结局
- Bladder cancer failure-free (BCFF) rates(2 years)
- Assessment of the effect of the combined treatment on the quality of life(2 years)
- Incidence Rate of treatment-related adverse event (safety and tolerability)(2 years)
- Median overall survival (OS)(2 years)