在先进的皮肤黑色素瘤中,卡博赞提尼布与潘布罗利祖马布联合进行了一项1b/2期研究
Yousef Zakharia1,2,3, Donghyun Kim1, Michele Freesmeier1,3
1Division of Hematology, Oncology, and Blood and Marrow Transplantation, Department of Internal Medicine, University of Iowa Health Care, Iowa City, Iowa, USA.
Cancer
|February 17, 2026
概括
这项研究探讨了卡博赞提尼布和潘布罗利祖马布用于晚期皮肤黑色素瘤 (aCM). 该组合显示了45%的整体反应率,但具有显著的毒性和中止率.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 有针对性的治疗.
背景情况:
- 布罗利祖马布已被批准用于晚期皮肤黑色素瘤 (aCM).
- 卡博桑提尼布是一种多氨酸激酶抑制剂,显示出抗瘤活性.
- 组合疗法可以改善aCM的结果.
研究的目的:
- 为了确定卡博桑提尼布与 pembrolizumab 结合用于aCM患者的安全性和疗效.
- 为了确定与pembrolizumab结合使用cabozantinib的推第二阶段剂量 (RP2D).
- 评估这种组合治疗的整体应答率 (ORR),无进展生存率 (PFS) 和整体生存率 (OS).
主要方法:
- 第1b/2期研究,包括28名无法切除的aCM患者.
- 阶段1b:增加卡博桑提尼布剂量 (20-60毫克) 与布罗利祖马布 (200毫克) 以找到RP2D.
- 第二阶段:西蒙两阶段设计,评估ORR,PFS和OS.
主要成果:
- 卡博桑提尼布的RP2D被确定为每天40毫克.
- 第二阶段由于积累较低而提前终止.
- 在2期的20名患者中,ORR为45%,PFS中位数为6.6个月,OS中位数为29.5个月.
- 常见的≥3级毒性包括高血压 (36%),低血 (18%) 和低血 (14%).
结论:
- 卡博赞提尼布和潘布罗利祖马布组合在未经治疗的aCM中进行了探索.
- 毒性概况与已知的药物概况一致.
- 由于毒性而导致的停药率显著.
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