A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
Phase 2
Active, not recruiting
NCT02519348
| Condition | Hepatocellular Carcinoma |
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| Phase | Phase 2 |
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| Sponsor | MedImmune LLC |
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| Status | Active, not recruiting |
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| Enrollment | 433 participants |
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| Interventions | Tremelimumab, Durvalumab, Bevacizumab |
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| Start date | Oct 19, 2015 |
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| Completion date | Nov 6, 2020 |
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| Results posted | Dec 6, 2021 |
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Summary
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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Open in BENITIONS
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