CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
2/3期
提前终止
NCT04695977
| 适应症 | Melanoma, Advanced Melanoma, Metastatic Melanoma, Unresectable Melanoma |
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| 分期 | 2/3期 |
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| 申办方 | Regeneron Pharmaceuticals |
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| 状态 | 提前终止 |
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| 受试者人数 | 20 人 |
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| 干预（药物） | CMP-001, Nivolumab |
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| 开始日期 | 2021年2月24日 |
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| 完成日期 | 2024年7月22日 |
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| 结果公布日 | 2025年9月5日 |
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摘要
CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma. The secondary objectives of Phase 3 are to: * To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. * To eva
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)
Up to approximately 39 months · Percentage of participants
| Nivolumab Monotherapy | 73 Percentage of participants |
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| CMP-001 and Nivolumab | 44 Percentage of 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。