A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 123
- 主要终点
- Complete Response Rate (CRR)
研究概览
简要总结
This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
详细描述
Eligible patients received 6 once-weekly intravesical instillations of UGN-102.
All patients returned to the clinic approximately 3 months after the first instillation for determination of response to treatment. Assessment of response was based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab.
Patients who had a complete response (CR) at the 3-month Visit, defined as having no detectable disease in the bladder, entered the Follow-up Period of the study. Patients who had a non-complete response (NCR) due to residual LG disease underwent investigator-designated standard of care (SOC) treatment of remaining lesions and then entered the Follow-up Period of the study.
During the Follow-up Period, patients return to the clinic every 3 months for up to 24 months (ie, 27 months after the first instillation) for evaluation of response. Patients who remain disease free at the 27-month Visit will continue to be followed every 6 months for up to 36 months (ie, 63 months after the first instillation) or until disease recurrence, disease progression, death, or the study is closed by the sponsor, whichever occurs first.
Patients who had a disease recurrence during the Follow-up Period or a disease progression at any time underwent investigator-designated SOC treatment and had a separate End of Study (EOS) Visit performed. The timing of the EOS Visit was approximately 3 months after SOC treatment of disease recurrence or progression.
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
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.
- •Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
- •History of LG-NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.
- •Has intermediate-risk disease, defined as having 1 or 2 of the following:
- •Presence of multiple tumors;
- •Solitary tumor > 3 cm;
- •Early or frequent recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis at the initial Screening Visit).
- •Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening.
- •Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
- •Leukocytes ≥ 3,000 per μL;
- •Absolute neutrophil count ≥ 1,500 per μL;
- •Platelets ≥ 100,000 per μL;
- •Hemoglobin ≥ 9.0 g/dL;
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- •Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN;
- •Alkaline phosphatase ≤ 2.5 × ULN;
- •Estimated glomerular filtration rate ≥ 30 mL/min.
- •Has an anticipated life expectancy of at least the duration of the trial.
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.
排除标准
- •Received Bacillus Calmette-Guérin treatment for urothelial carcinoma (UC) within previous 1 year.
- •History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years.
- •Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed.
- •Clinically significant urethral stricture that would preclude passage of a urethral catheter.
- •History of:
- •Neurogenic bladder;
- •Active urinary retention;
- •Any other condition that would prohibit normal voiding.
- •Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC.
- •Current tumor grading of T
- •Concurrent upper tract UC.
- •Evidence of active urinary tract infection that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment.
- •Is pregnant or breastfeeding.
- •Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol.
- •History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT.
- •Has participated in a study with an investigational agent or device within 30 days of enrollment.
- •Has previously participated in a study in which they received UGN-
- •Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed.
- •Has any other clinically significant medical or surgical condition that in the Investigator's opinion could compromise patient safety or the interpretation of study results.
研究组 & 干预措施
UGN-102
Patients will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
干预措施: UGN-102 (Drug)
结局指标
主要结局
Complete Response Rate (CRR)
时间窗: 3 months
CRR is defined as the percentage of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions (if applicable), and voiding urine cytology.
次要结局
- Duration of Response (DOR) in Patients Who Achieved CR at the 3-month Visit(Up to 60 months)
- Durable Complete Response (DCR) Rate in Patients Who Achieved CR at the 3-month Visit(Up to 60 months)
- Disease-free Survival (DFS) in Patients Who Achieved CR at the 3-month Visit(Up to 63 months)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest(Up to 21 months)
- Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values(6 months)
- Number of Participants With Post-baseline PCS Chemistry Values(6 months)
研究者
研究点 (123)
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