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 (HCC) Patients Who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 59
- 主要终点
- Best Overall Response (BOR) per Investigator
研究概览
简要总结
Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), lenvatinib, or sorafenib. Approximately 120 adult participants will be enrolled in the study across 60 sites worldwide.
In arm 1 (control), participants will receive the investigator's choice: lenvatinib as an oral capsule or sorafenib as an oral tablet, once daily. In arm 2, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab, every 3 weeks. In arm 3, participants will receive intravenously (IV) infused livmoniplimab (dose B) in combination with IV infused budigalimab, every 3 weeks. The estimated duration of the study is up to 2 years
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child-Pugh A classification.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen.
- •Adequate hematologic and end-organ function.
- •Tissue biopsy at screening.
- •Disease that is not amenable to surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.
排除标准
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- •Prior treatment with an approved tyrosine kinase inhibitor (for example sorafenib or Lenvatinib) in 1L HCC treatment regimen.
- •History of malignancy other than hepatocellular carcinoma (HCC) within 5 years prior to screening.
- •Hepatic encephalopathy or requirement for medications to prevent or control encephalopathy.
- •Moderate or severe ascites requiring recurrent non-pharmacologic intervention to maintain symptomatic control.
- •Coinfection with active HBV infection and active HCV infection.
- •Prior history of grade 3 or higher immune-mediated adverse event or discontinuation due to immune-mediated adverse events.
- •Prior history of recurrent grade 2 or higher interstitial lung disease/pneumonitis.
研究组 & 干预措施
Arm 1: Lenvatinib or Sorafenib
Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
干预措施: Lenvatinib (Drug)
Arm 1: Lenvatinib or Sorafenib
Participants will receive Lenvatinib or or Sorafenib, as part of an approximately 2 year treatment period.
干预措施: Sorafenib (Drug)
Arm 2: Livmoniplimab Dose A + Budigalimab
Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
干预措施: Budigalimab (Drug)
Arm 2: Livmoniplimab Dose A + Budigalimab
Participants will receive Livmoniplimab Dose A in combination with budigalimab, as part of an approximately 2 year treatment period.
干预措施: Livmoniplimab (Drug)
Arm 3: Livmoniplimab Dose B + Budigalimab
Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
干预措施: Budigalimab (Drug)
Arm 3: Livmoniplimab Dose B + Budigalimab
Participants will receive Livmoniplimab Dose B in combination with budigalimab, as part of an approximately 2 year treatment period.
干预措施: Livmoniplimab (Drug)
结局指标
主要结局
Best Overall Response (BOR) per Investigator
时间窗: Through Study Completion, Up to Approximately 27 Months
BOR is defined as a subject achieving confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by investigators at any time prior to subsequent anticancer therapy.
次要结局
- Duration of response (DOR) per Investigator(Through Study Completion, Up to Approximately 27 Months)
- Number of Participants with Progression-free Survival (PFS)(Through Study Completion, Up to Approximately 27 Months)
- Overall Survival (OS)(Through Study Completion, Up to Approximately 27 Months)