NCT06319820招募中3 期
A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 641
- 试验地点
- 366
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk 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
- •Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than [<] 1 year), iv. Frequent recurrence (greater than [>] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
- •Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and >=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor >=3 cm
- •Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
- •Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
- •Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
- •Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- •Have an Eastern Cooperative Oncology Group performance status of 0 to 2
排除标准
- •Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
- •Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
- •Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
- •Current indwelling urinary catheters, however, intermittent catheterization is acceptable
- •Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)
- •- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis
研究组 & 干预措施
Substudy: Group A: TAR-210
Experimental
Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
干预措施: TAR-210 (Combination Product)
Main Study: Group A: TAR-210
Experimental
Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
干预措施: TAR-210 (Combination Product)
Main Study: Group B: MMC or Gemcitabine
Active Comparator
Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
干预措施: Gemcitabine (Drug)
Main Study: Group B: MMC or Gemcitabine
Active Comparator
Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
干预措施: MMC (Drug)
Substudy: Group B: MMC
Active Comparator
Participants in substudy Group B will receive intravesical MMC once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
干预措施: MMC (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)
DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
次要结局
- European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores(Baseline, Weeks 6, 12, 24, 36, and 48)
- Time to next Treatment (TTNT)(From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months))
- High Grade Recurrence-free Survival (HG RFS)(From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months))
- Progression Free Survival (PFS)(From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months))
- Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)(From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months))
- Overall Survival (OS)(From randomization to the date of death (approximately 4 years and 2 months))
- European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores(Baseline, Weeks 6, 12, 24, 36, and 48)
- Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores(Weeks 6, 12, 24, 36, and 48)
- Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores(Weeks 6, 12, 24, 36, and 48)
- Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment(From study treatment completion up to trial discontinuation (approximately 4 years and 2 months))
研究者
研究点 (366)
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相关资讯
Johnson & Johnson's Erda-iDRS Shows 89% Complete Response Rate in First-in-Human Bladder Cancer Study- Johnson & Johnson's investigational Erda-iDRS achieved an 89% complete response rate in intermediate-risk non-muscle-invasive bladder cancer patients with FGFR alterations in a Phase 1 study.
- The intravesical drug delivery system demonstrated durable responses with a median duration of 18 months and showed encouraging recurrence-free survival outcomes in high-risk patients.
- The treatment was generally well tolerated with predominantly local adverse events, supporting advancement to ongoing Phase 2 and Phase 3 trials in the MoonRISe program.
- Erda-iDRS represents a potential first targeted therapy for early-stage bladder cancer, delivering erdafitinib directly to the bladder to minimize systemic exposure.6 months agoTAR-210 Shows Promise in FGFR-Altered Non-Muscle Invasive Bladder Cancer- TAR-210, an intravesical delivery system for erdafitinib, demonstrates early clinical activity in patients with FGFR-altered high- and intermediate-risk NMIBC.
- In high-risk NMIBC patients, TAR-210 achieved an estimated 12-month recurrence-free survival rate of 90% at a median follow-up of 8.9 months.
- Among intermediate-risk NMIBC patients, TAR-210 showed a 90% complete response rate at 12 weeks, with 86% of complete responses ongoing at data cutoff.
- A phase 3 study (MoonRISe-1) is underway to compare TAR-210 to standard of care in FGFR-altered intermediate-risk NMIBC.last year