NCT07480356招募中3 期
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 10
- 主要终点
- Incidence of high-grade complete response
研究概览
简要总结
The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.
The main questions it aims to answer are:
- Can the study drug help participants with this type of cancer?
- Is the study drug safe?
- What are the side effects of the study drug?
Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.
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
- •Male or female participants 18 years of age or older at the time of signing informed consent
- •Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
- •Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
- •Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis
排除标准
- •Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
- •Central confirmed variant histology
- •Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
- •Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
- •Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history
- •For more information on eligibility criteria, please contact the Sponsor.
研究组 & 干预措施
Investigator's choice of intravesical chemotherapy
Active Comparator
干预措施: Investigator's Choice of Intravesical Chemotherapy (Drug)
TARA-002 (Arm A)
Experimental
干预措施: TARA-002 (Drug)
结局指标
主要结局
Incidence of high-grade complete response
时间窗: Month 6
Incidence of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable)
次要结局
- Overall survival(Up to Month 60)
- Duration of high-grade complete response(Up to Month 60)
- Treatment emergent adverse events(Up to Month 60)
- Treatment emergent serious adverse events(Up to Month 60)
- High-grade complete response rate(At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60)
- High-grade complete response rate (CIS only)(Month 6)
- Event-free survival(Up to Month 60)
- Recurrence-free survival(Up to Month 60)
- Progression-free survival(Up to Month 60)
- Disease-specific progression-free survival(Up ro Month 60)
- Disease-specific survival(Up to Month 60)
- Time to cystectomy(Up to Month 60)
- Time to recurrence delayed cystectomy(Up to Month 60)
- Time to progression(Up to Month 60)
- Time to disease worsening(Up to Month 60)
研究者
研究点 (10)
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