A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
2期
进行中（已停止招募）
NCT02519348
| 适应症 | Hepatocellular Carcinoma |
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| 分期 | 2期 |
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| 申办方 | MedImmune LLC |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 433 人 |
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| 干预（药物） | Tremelimumab, Durvalumab, Bevacizumab |
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| 开始日期 | 2015年10月19日 |
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| 完成日期 | 2020年11月6日 |
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| 结果公布日 | 2021年12月6日 |
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摘要
This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.
Number of Participants With Dose Limiting Toxicities (DLTs)
From Day 1 to Day 28 after first dose of study drug · Participants
| Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 0 Participants |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) · Participants
| Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 38 Participants |
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| Parts 2 and 3: Durvalumab 1500 mg | 95 Participants |
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| Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | 73 Participants |
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| Parts 2 and 3: Tremelimumab 750 mg | 67 Participants |
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| Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | 80 Participants |
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| Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | 45 Participants |
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Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) · Participants
| Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg | 0 Participants |
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| Parts 2 and 3: Durvalumab 1500 mg | 5 Participants |
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| Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg | 6 Participants |
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| Parts 2 and 3: Tremelimumab 750 mg | 6 Participants |
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| Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg | 6 Participants |
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| Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg | 0 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。