JPRN-jRCT2080223439已完成1 期
An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
研究概览
简要总结
envatinib 8 mg (<60 kg body weight [BW]) or 12 mg (>=60 kg BW) daily with pembrolizumab 200 mg intravenous (every 3 weeks) demonstrated a clinically meaningful ORR, long DOR, and noteworthy depth of response. Overall, no new safety signals or risks were identified for either lenvatinib or pembrolizumab. The safety profile is manageable, and observed toxicities were generally similar to those previously reported in the reference safety information for lenvatinib and pembrolizumab.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Confirmed diagnosis of hepatocellular carcinoma (HCC)
- •(2)HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
- •(3)Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
- •(4)At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
- •(5)Child-Pugh score A
- •(6)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
- •(7)Adequately controlled blood pressure
- •(8)Adequate renal function
- •(9)Adequate bone marrow function
- •(10)Adequate blood coagulation function
- •(11)Adequate liver function
- •(12)Males or females age >= 18 years at the time of informed consent
- •(13)Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
排除标准
- •(1)Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- •(2)Any current brain or subdural metastases
- •(3)Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
- •(4)Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
研究者
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