CTRI/2021/10/037225进行中（未招募）3 期
A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder who are not Receiving Radical Cystectomy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
- 试验地点
- 9
- 主要终点
- Time from Randomization to the First Bladder Intact Event-free Survival (BIEFS) event
研究概览
简要总结
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.
TAR-200 is an investigational drug delivery system. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed cell death protein 1 (PD-1). Study consists of screening phase of 42 days, treatment phase and follow up phase. The total duration of study will be up to 8 years. Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant treatments/procedures and adverse event monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Ineligible for or have elected not to undergo radical cystectomy.
- •All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than 2 prior to randomization.
- •Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or
- •Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment.
- •Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to 1500/cubic millimeters; Platelet count greater than or equal to 80,000/cubic millimeters; Hemoglobin greater than or equal to 9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) or direct bilirubin less than or equal to ULN for participants with total bilirubin levels greater than 1.5 times ULN (except participants with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times institutional ULN); Renal function: Creatinine clearance greater than 40 mL/min either directly measured via 24-hour urine collection, calculation using the Cockcroft-Gault formula, or calculation for the modification of diet in renal disease for adult participants.
排除标准
- •Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephrouretrectomy more than 24 months prior to initiating study.
- •Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multifocal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT.
- •Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization.
- •Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR
- •Evidence of bladder perforation during diagnostic cystoscopy.
结局指标
主要结局
Time from Randomization to the First Bladder Intact Event-free Survival (BIEFS) event
时间窗: Up to 8 years
次要结局
- Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)(Up to 8 years)
- Metastasis-free survival (MFS)(Up to 8 years)
- Overall Survival (OS)(Up to 8 years)
- Overall Response Rate (ORR)(Up to 8 years)
- Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)(Up to 8 years)
- Number of Participants with Clinical Laboratory Abnormalities(Up to 8 years)
研究者
研究点 (9)
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