NCT06510374招募中3 期
A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Ferring Pharmaceuticals139 个研究点 分布在 3 个国家目标入组 454 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 454
- 试验地点
- 139
- 主要终点
- Recurrence Free survival
研究概览
简要总结
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR 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
- •Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)
- •Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
- •Recurrence within 1 year, low-grade Ta
- •Solitary low-grade Ta >3 cm
- •Low-grade Ta, multifocal
- •Solitary high-grade Ta, ≤3 cm
- •Low-grade T1
- •Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
- •Restage TURBT may be done at the discretion of the investigator
排除标准
- •Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
- •High risk NMIBC defined as:
- •High-grade T1
- •Any recurrent, high-grade Ta
- •High-grade Ta >3 cm (or multifocal)
- •Any carcinoma in situ (CIS)
- •Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
- •Any variant histology
- •Any prostatic urethral involvement
- •Low risk NMIBC defined as:
- •First occurrence of low-grade solitary Ta ≤3 cm
- •Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
- •Papillary urothelial neoplasm of low malignant potential
研究组 & 干预措施
Arm 2 - Observation
No Intervention
Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period.
.
Arm 1 Nadofaragene Firadenovec
Experimental
Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits.
干预措施: Nadofaragene Firadenovec (Drug)
结局指标
主要结局
Recurrence Free survival
时间窗: 24 months
Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period.
次要结局
- Adverse Events(up to 24 months)
- Recurrence Free Survival at 12 Months(12 months)
- Recurrence Free Survival at 24 Months(24 Months)
研究者
研究点 (139)
Loading locations...
相似试验
招募中
3 期
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder CancerNCT06545955Ferring Pharmaceuticals250
已完成
3 期
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea PedisAthlete's FootTinea PedisNCT00750139Merz North America, Inc.707
已完成
3 期
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea CrurisJock ItchTinea CrurisNCT00750152Merz North America, Inc.334
招募中
1 期
Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal PelvisNCT06668493Ferring Pharmaceuticals20
已完成
3 期
Tapinarof for the Treatment of Atopic Dermatitis in Children and AdultsAtopic DermatitisNCT05014568Organon and Co407
相关资讯
Real-World Data and Ongoing Trials Highlight Efficacy of Nadofaragene Firadenovec in Bladder Cancer- Real-world data presented at the 2025 ASCO Genitourinary Cancers Symposium indicates nadofaragene firadenovec demonstrates positive efficacy and safety outcomes in treating NMIBC.
- The ABLE-32 phase 3B trial is underway to assess nadofaragene firadenovec in intermediate-risk NMIBC patients, addressing the unmet need for FDA-approved treatments.
- Additional trials, including ABLE-22 and LUNAR, are exploring nadofaragene firadenovec as a monotherapy, in combination with other treatments, and in low-grade upper tract urothelial carcinoma.
- Nadofaragene firadenovec, the first FDA-approved intravesical gene therapy, offers a novel approach by turning bladder wall cells into interferon microfactories to fight cancer.last yearFerring Advances Nadofaragene Firadenovec Clinical Program in Urothelial Cancers- Ferring Pharmaceuticals is expanding the clinical trial program for nadofaragene firadenovec, an intravesical gene therapy, to include intermediate-risk NMIBC and low-grade UTUC.
- A Phase 2 trial (ABLE-22) will evaluate nadofaragene firadenovec alone or with chemotherapy/immunotherapy in high-risk BCG-unresponsive NMIBC, including re-induction for non-responders.
- The Phase 3B ABLE-32 trial will assess nadofaragene firadenovec in intermediate-risk NMIBC, an area with no FDA-approved treatments, using recurrence-free survival as the primary endpoint.
- The LUNAR trial is initiated to study nadofaragene firadenovec in patients with low-grade upper tract urothelial cancer (UTUC), addressing a significant unmet need.last year