IZABRIGHT-BLADDER01: A Randomized, Open-label, Phase 2/3 trial of Izalontamab Brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Phase 2: Will be assessed by reviewing all available data, including efficacy, safety, tolerability, and pharmacokinetic data.
研究概览
简要总结
Phase 2: To determine the recommended dose of iza-bren to be used in Phase 3 of the trial. Phase 3: To evaluate the efficacy endpoints of iza-bren compared to Platinum based chemotherapy (PBC). Efficacy endpoints are measurements that look at how well the study treatment works.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •People with a metastatic urothelial cancer, confirmed by looking at tissue or cell samples, whose disease has worsened on or after an immunotherapy-based treatment.
- •To be eligible for this trial, patients must have not been treated previously with more than two types of systemic cancer treatment.
- •To be part of this study, the patient's cancer must have grown or come back after being treated with a type of medicine (also known as anti-PD-(L)1 therapy) that helps the body's immune system fight cancer. It could have been used alone or with other treatments, but patients must have had at least one other treatment in addition to the anti-PD-(L)1 therapy. However, if the patient only had this therapy for a type of bladder cancer that has not spread to other parts of the body, they can't be part of this study.
- •Also, if the patient had anti-PD-(L)1 therapy as part of their surgery preparation or recovery, they may be eligible to participate if certain other conditions are met.
- •The study also involves a treatment called PBC, which uses drugs called cisplatin or carboplatin. So, patients need to be able to take these drugs.
排除标准
- •If patients have had a treatment with PBC before, they need to have stopped taking them for at least a year to be part of this study.
- •Patients who did not respond well to previous PBC treatments, meaning their cancer did not shrink or were stable for less than 6 months, can't join this study.
结局指标
主要结局
Phase 2: Will be assessed by reviewing all available data, including efficacy, safety, tolerability, and pharmacokinetic data.
Phase 2: Will be assessed by reviewing all available data, including efficacy, safety, tolerability, and pharmacokinetic data.
Phase 3: Efficacy will be evaluated by comparing progression-free survival (time from start of treatment until worsening of disease or death, whichever comes first) and overall survival (how long a patient lives) between iza-bren and PBC.
Phase 3: Efficacy will be evaluated by comparing progression-free survival (time from start of treatment until worsening of disease or death, whichever comes first) and overall survival (how long a patient lives) between iza-bren and PBC.
次要结局
- Phase 2 and 3: Additional efficacy endpoints will be tested in both groups of patients, including what proportion of participants respond to treatment (objective response rate), how long until participants respond to treatment (time to response), how long a participants’ response to treatment lasts (duration of response), time without cancer growing (progression free survival) and how long patients survive (overall survival).
- In Phase 3 only, the time it takes for participants to report a decline in their quality of life will be measured and compared.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company