A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
第2相
実施中（募集終了）
NCT02519348
| 対象疾患 | Hepatocellular Carcinoma |
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| 相 | 第2相 |
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| スポンサー | MedImmune LLC |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 433 名 |
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| 介入（薬剤） | Tremelimumab, Durvalumab, Bevacizumab |
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| 開始日 | 2015年10月19日 |
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| 完了日 | 2020年11月6日 |
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| 結果公開日 | 2021年12月6日 |
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概要
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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