A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab for locally advanced or Metastatic Hepatocellular Carcinoma patients who have progressed after an approved immune checkpoint inhibitor containing regimen in First-Line HCC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 20
- 主要终点
- The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.
研究概览
简要总结
To optimize livmoniplimab dose in combination with budigalimab and identify the recommended phase 3 dose in locally advanced or metastatic Child-Pugh A HCC patients who have progressed after an immune CPI-containing regimen in 1L HCC. To evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by the rate of BOR of confirmed CR/PR determined by investigators.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Child-Pugh A ECOG PS 0-1 Received an immune checkpoint inhibitor in 1L HCC treatment regimen.No symptomatic, untreated, or actively progressing CNS metastases. Adequate hematologic and end-organ function Tissue biopsy at screening
排除标准
- •No history of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%),
- •No major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •No prior allogeneic stem cell or solid organ transplantation
- •Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade ≤ 1 prior to study entry, except for alopecia.
- •Negative HIV test at screening due to potential safety concerns on those immune compromised patients.
结局指标
主要结局
The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.
The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.
次要结局
- The secondary endpoints are DoR by investigators, PFS by investigators, and OS.
- PFS by investigators: The time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
- OS: The time from randomization until death from any cause.
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG