A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 15
- 主要终点
- Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS
研究概览
简要总结
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
详细描述
An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.
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
- •In order to be eligible for participation in this trial, the patient must:
- •Be ≥18 years of age on day of signing informed consent.
- •- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease.
- •Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
- •Demonstrate adequate organ function.
- •Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
- •Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.
排除标准
- •Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
- •History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.
- •Has received systemic anti-cancer therapy, including investigational agents.
- •Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
- •Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
- •Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.
研究组 & 干预措施
CG0070
Patients with CIS with or without HG Ta/T1 papillary disease. CG0070 will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly for specific schedule per protocol.
干预措施: CG0070 (Biological)
CG0070
Patients with CIS with or without HG Ta/T1 papillary disease. CG0070 will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly for specific schedule per protocol.
干预措施: DDM (Other)
结局指标
主要结局
Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS
时间窗: 36 months
次要结局
- Duration of response (DOR)(36 months)
- Assess high-grade reoccurrence free survival (RFS)(36 months)
- Assess progression free survival (PFS)(36 months)
- Complete response rate at 12, 24, and 36 months(Assessed at 12, 24, and 36 months)
- Overall survival rate at 36 months(36 months)
- Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE)(36 months)