NCT07106762招募中2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 470
- 试验地点
- 308
- 主要终点
- Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
研究概览
简要总结
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
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
- •Participants must have histologically confirmed advanced urothelial carcinoma.
- •Participants must be eligible to receive platinum-based chemotherapy.
- •Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
- •Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
- •Participants must have ≥ 1 measurable lesion per RECIST v1.
- •Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
排除标准
- •Participants must not have platinum-based chemotherapy exposure within 12 months.
- •Participants must not have received >2 prior regimens irrespective of the setting.
- •Participants must not have prior ADC therapy targeting EGFR or HER
- •Participants must not have prior therapy with topoisomerase 1 inhibitor.
- •Participants must not have active, untreated brain metastases.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Arm E
Active Comparator
干预措施: Cisplatin (Drug)
Arm E
Active Comparator
干预措施: Gemcitabine (Drug)
Arm E
Active Comparator
干预措施: Carboplatin (Drug)
Arm B
Experimental
干预措施: Iza-bren (Drug)
Arm A
Experimental
干预措施: Iza-bren (Drug)
Arm D
Experimental
干预措施: Iza-bren (Drug)
Arm C
Active Comparator
干预措施: Cisplatin (Drug)
Arm C
Active Comparator
干预措施: Carboplatin (Drug)
Arm C
Active Comparator
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
时间窗: Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
时间窗: Up to 5 years
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Phase 3: Overall Survival (OS)
时间窗: Up to 5 years
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
时间窗: Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
时间窗: Up to 5 years
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Phase 3: Overall Survival (OS)
时间窗: Up to 5 years
次要结局
- Phase 2: Objective Response (OR)(Up to 5 years)
- Phase 2: PFS(Up to 5 years)
- Phase 2: Duration of Response (DOR)(Up to 5 years)
- Phase 2: Time to Response (TTR)(Up to 5 years)
- Phase 2: OS(Up to 5 years)
- Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration(Up to 5 years)
- Phase 2: Iza-bren total antibody concentration(Up to 5 years)
- Phase 2: Iza-bren Ed-04 payload concentration(Up to 5 years)
- Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)(Up to 5 years)
- Phase 2: Iza-bren trough observed concentration (Ctrough)(Up to 5 years)
- Phase 3: OR(Up to 5 years)
- Phase 3: DoR(Up to 5 years)
- Phase 3: TTR(Up to 5 years)
- Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale(Up to 5 years)
- Phase 2: Objective Response (OR)(Up to 5 years)
- Phase 2: PFS(Up to 5 years)
- Phase 2: Duration of Response (DOR)(Up to 5 years)
- Phase 2: Time to Response (TTR)(Up to 5 years)
- Phase 2: OS(Up to 5 years)
- Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration(Up to 5 years)
- Phase 2: Iza-bren total antibody concentration(Up to 5 years)
- Phase 2: Iza-bren Ed-04 payload concentration(Up to 5 years)
- Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)(Up to 5 years)
- Phase 2: Iza-bren trough observed concentration (Ctrough)(Up to 5 years)
- Phase 3: OR(Up to 5 years)
- Phase 3: DoR(Up to 5 years)
- Phase 3: TTR(Up to 5 years)
- Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale(Up to 5 years)
研究者
研究点 (308)
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