A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH ADVANCED LIVER CANCERS (MORPHEUS LIVER)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- 1. ORR (determined by the investigator according to RECIST 1.1)
研究概览
简要总结
To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response rate (ORR) as determined by the investigator according to RECIST v1.1 and to evaluate the safety of immunotherapy-based treatment combinations
研究设计
- 分配方式
- Randomized
- 主要目的
- A Phase Ib/ii Safety And Efficacy Study In Patients With Advanced Liver Cancers
- 盲法
- None
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
- 是
入选标准
- •Age ≥ 18 years, with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
- •Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients
- •Child-Pugh class A within 7 days prior to randomization
- •Disease that is not amenable to curative surgical and/or locoregional therapies
- •No prior systemic treatment (including systemic investigational agents) for HCC
- •Life expectancy ≥ 3 months, as determined by the investigator and availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status via central testing
排除标准
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2alpha
- •Treatment with investigational therapy within 28 days prior to initiation of study
- •Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure
- •Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding
- •A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study
- •AEs from prior anti-cancer therapy that have not resolved to Grade 1 or better, with the exception of alopecia of any grade
结局指标
主要结局
1. ORR (determined by the investigator according to RECIST 1.1)
1. ORR (determined by the investigator according to RECIST 1.1)
2. Incidence, nature, and severity of adverse events and laboratory abnormalities
2. Incidence, nature, and severity of adverse events and laboratory abnormalities
3. Change from baseline in vital signs and ECG parameters
3. Change from baseline in vital signs and ECG parameters
4. Change from baseline in targeted clinical laboratory test results
4. Change from baseline in targeted clinical laboratory test results
次要结局
- 1. PFS
- 2. OS after randomization
- 3. OS at specific timepoints
- 4. DOR
- 5. Disease control
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG