BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- BCG ImmunoScore
研究概览
简要总结
This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.
详细描述
BCG immunotherapy is the current gold standard for NMIBC. However, ~50% of patients will eventually experience recurrence or progression. Pre-treatment immune competence of the patient, the bladder microenvironment and systemic immune responses to immunomodulation by BCG govern effectiveness. The investigators intend to utilize a novel tumor tissue and blood based biomarker test to assess early systemic responses to standard of care BCG based immunotherapy as well as alternate strategies to enhance immune responses as measured systemically as well as based on early response rates (3 month complete response or 3 month recurrence). The goal of this study is to develop strategies to identify novel more effective anti-tumor immune responses for NMIBC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).
- •Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.
- •Participants older than 65 years of age.
排除标准
- •Patients with prior exposure to BCG immunotherapy.
- •Immunosuppressed patients on steroids, transplants etc.
研究组 & 干预措施
Intravesical Gemcitabine + BCG
Patients will be recruited to treatment with gemcitabine at week 0 following which BCG (50 mg, TICE strain) will be administered once every week for a total of 5 instillations.
干预措施: Gemcitabine + BCG (Drug)
Intravesical Bacillus Calmette-Guérin (BCG)
6 intravesical instillations of BCG (50 mg, TICE strain) at weekly intervals.
干预措施: BCG (TICE strain) (Drug)
结局指标
主要结局
BCG ImmunoScore
时间窗: 3 months
Complete response at 3 months with no evidence of tumor recurrence as assessed by biopsy. Demonstrable immunological responses measured at weeks 2, and 5 post-treatment, based on a novel tissue and blood based immune biomarker.
次要结局
- Recurrence free survival(12 months)
研究者
Madhuri Koti
Associate Professor
Queen's University