CTRI/2025/07/091091尚未招募不适用
An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)
Seagen Inc., a wholly owned subsidiary of Pfizer9 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- 1. To compare the efficacy of disitamab vedotin in combination with pembrolizumab to chemotherapy as firstline treatment in participants with advanced UC that expresses HER2.
研究概览
简要总结
This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC.
Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced).
In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
- •Measurable disease by investigator assessment per RECIST v1.
- •Participant must not have received prior systemic therapy for LA/mUC.
- •Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression occurred more than 12 months after the last dose of therapy.
- •If archival tissue is not available a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day
- •HER2 expression of 1+ or greater on immunohistochemistry (IHC).
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.
排除标准
- •Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.
- •History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded. Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated 3.CNS metastases are permitted if all of the following are met.
- •CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.
- •Participant is on a stable dose of less than equal to 10 mg/day of prednisone or equivalent for at least 2 weeks.
- •History of or active autoimmune disease that has required systemic treatment in the past 2 years.
- •Prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists).
- •Prior solid organ or bone marrow transplantation.
- •Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
- •Estimated life expectancy less than 12 week
- •Prior treatment with an MMAE agent or anti-HER2 therapy.
结局指标
主要结局
1. To compare the efficacy of disitamab vedotin in combination with pembrolizumab to chemotherapy as firstline treatment in participants with advanced UC that expresses HER2.
时间窗: 1. Approximately 3 years | 2. Approximately 5 years
2. Overall survival (OS)
时间窗: 1. Approximately 3 years | 2. Approximately 5 years
次要结局
- DCR per RECIST v1.1 by investigator assessment(Approximately 3 years)
- Objective response rate (ORR) per RECIST v1.1 by BICR(Approximately 3 years)
- ORR per RECIST v1.1 by investigator assessment(Approximately 3 years)
- Duration of Response (DOR) per RECIST v1.1 by BICR(Approximately 3 years)
- DOR per RECIST v1.1 by investigator assessment(Approximately 3 years)
- Control Rate (DCR) per RECIST v1.1 by BICR(Approximately 3 years)
- PFS per RECIST v1.1 by investigator assessment(Approximately 3 years)
- Number of participants with adverse events (AEs)(Through 30 days after the last study treatment; approximately 2 years)
- Change from baseline of left ventricular ejection fraction (LVEF)(Through 2 years after last study treatment; approximately 4 years)
- Change from baseline to Week 16 in European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score(Approximately 2 years)
- Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score(Approximately 2 years)
- Time to pain progression(Approximately 2 years)
研究者
研究点 (9)
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