DART/SWOG/NCI第二阶段抗CTLA-4/PD-1试验:卵巢,子宫内膜,子宫的明细胞癌
Young Kwang Chae1, Megan Othus2, Sandip P Patel3
1Northwestern University, Chicago, Illinois, USA chaelabmeeting@gmail.com patel@ucsd.edu rkurzrock@mcw.edu.
Journal for immunotherapy of cancer
|February 11, 2026
概括
用伊皮利穆马布和尼沃卢马布进行的双重免疫疗法在妇科清细胞癌 (CCCs) 中显示出持久的抗瘤活性. 卵巢CCC患者经历了显著的反应,这表明这种组合治疗在罕见的,侵略性的癌症中具有潜力.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 妇科癌症 妇科癌症
背景情况:
- 双抗CTLA-4/PD-1抑制剂在各种癌症中有效.
- 妇科明显细胞癌 (CCCs) 是罕见的和积极的.
- 这项研究是第一个在专门的妇科CCC队列中评估ipilimumab-nivolumab的研究.
研究的目的:
- 评估在患有妇科性CCC的患者中Ipilimumab加Nivolumab的疗效.
- 为了确定整体反应率 (ORR),无进展生存率 (PFS) 和整体生存率 (OS).
- 评估组合治疗的安全性和毒性概况.
主要方法:
- 一个多中心的II期试验 (DART) 涉及32名患有妇科CCC的患者.
- 患者接受了伊皮利马布 (1 mg/kg IV q6w) 加上尼沃马布 (240 mg IV q2w).
- 主要终点是基于RECIST的ORR;次要终点包括iRECIST ORR,PFS,OS,临床益处率 (CBR) 和毒性.
主要成果:
- 观察到的整体ORR为9.38%,在卵巢CCC中有两个完全响应 (CR) 和一个部分响应 (PR).
- 使用iRECIST的ORR增加到12.5%,包括宫CCC的持久PR.
- 临床益处率 (CBR) 为21.88%,所有患者的中位数生存期为21.7个月.
结论:
- 伊皮利穆马布加尼沃卢马布在精选的妇科CCC患者中表现出持久的抗瘤活性,特别是那些来自卵巢的患者.
- 安全性概况与已知的伊皮利穆马布和尼沃卢穆马布毒性相一致.
- 目前正在进行的相关研究旨在确定治疗反应的预测生物标志物.
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