A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Event free survival
研究概览
简要总结
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.
详细描述
HERO: A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined with Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients with HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
This Phase 3, open-label, randomized, controlled clinical trial will enroll approximately 182 patients, who will be assigned in a 1:1 ratio to one of two treatment groups:
Group A: Disitamab Vedotin plus BCG (induction and maintenance therapy)
Group B: BCG alone (induction and maintenance therapy)
The study is designed to demonstrate the superiority of Disitamab Vedotin combined with BCG (during both induction and maintenance phases) over BCG alone in prolonging event-free survival (EFS) among BCG-naïve participants with high-risk, HER2-expressing non-muscle invasive bladder cancer.
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
- •Age ≥ 18 years.
- •Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with >50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).
- •Complete resection of all Ta/T1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.
- •HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
- •Unwillingness or ineligibility to undergo radical cystectomy.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤
- •Signed informed consent form (ICF).
排除标准
- •Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.
- •Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
- •History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
- •Prior therapy with any other type of HER2-targeted inhibitor.
- •Major surgery within 2 weeks prior to randomization.
- •Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
研究组 & 干预措施
DV + BCG
Disitamab Vedotin + BCG induction and maintenance
干预措施: DV + BCG induction and maintenance (Drug)
结局指标
主要结局
Event free survival
时间窗: 55 months after first participant randomized
Event free survival is defined as the time from randomization to date of EFS event.
次要结局
- Overall Survival(Randomization up to 60 months from last participant randomized)
- Complete response rate at 6m/12m in participants with CIS at randomization(Randomization up to 12 months from last participant randomized)
- Disease-specific survival(Randomization up to 60 months from last participant randomized)
- Health-related quality of life as measured by EORTC QLQ-C30(Randomization up to 60 months from last participant randomized)
- Health-related quality of life as measured by EORTC QLQ-NMIBC24(Randomization up to 60 months from last participant randomized)
研究者
Ding-Wei Ye
Director of Urology
Fudan University