The phase II study of pembrolizumab plus lenvatinib for patients with unresectable cutaneous angiosarcoma (Pembro-Lenva for cAS / PLAS trial)

未提供0 个研究点目标入组 38 人开始时间: 2025年3月3日最近更新: 2025年5月7日

试验速览

暂无简介。

•Histologically diagnosed with cutaneous angiosarcoma, and having an unresectable primary or metastatic lesion
•Having at least one measurable lesion on the body surface that was confirmed by contrast-enhanced CT/MRI or visual inspection within 14 days before enrollment
•18 to 85 years old at enrollment
•With stable blood pressure at 150/90 mmHg or lower within 7 days before enrollment
•With healed wounds (if any) at enrollment
•Cooperative with highly effective contraception methods
•Having given written informed consent

•Patients previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, other agents targeting co-inhibitory T-cell receptors, or angiogenesis inhibitors
•Patients who received chemotherapy or radiotherapy within 28 days before enrollment, or who have not recovered from those toxicities
•Patients who used other investigational drugs or investigational medical devices within 28 days before enrollment
•Patients who received live or live attenuated vaccines within 30 days before enrollment
•Patients with other malignant tumors progressive or requiring aggressive treatment within the past 3 years
•Patients with active CNS metastasis or carcinomatous meningitis
•Patients with active autoimmune disease within 2 years before enrollment
•Patients with clinically significant cardiovascular diseases at NYHA class III or IV within 12 months before enrollment
•Patients with encasement or invasion of a major blood vessel, or intratumoral cavitation that was diagnosed radiographically within 14 days before enrollment
•Patients with active infections, gastrointestinal ulcer of Grade 3-4 or fistula, or conditions that might affect gastrointestinal absorption

objective response rate (centrally assessed)

发起方

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