A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
1/2期
已完成
NCT03294083
| 适应症 | Renal Cell Carcinoma |
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| 分期 | 1/2期 |
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| 申办方 | SillaJen, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 95 人 |
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| 干预（药物） | Pexastimogene Devacirepvec (Pexa-Vec), Cemiplimab |
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| 开始日期 | 2018年6月19日 |
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| 完成日期 | 2023年2月16日 |
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| 结果公布日 | 2026年6月18日 |
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摘要
This is a Phase 1b/2a, open-label, multi-center, dose-escalation and safety/efficacy evaluation trial of Pexa-Vec plus Cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with Cemiplimab will be determined, followed by an expansion stage. During the expansion patients will receive Cemiplimab alone or in combination with Pexa-Vec, which will be administered either through intravenous (IV) or intratumoral (IT) injection.
Number and Percentage of Participants With Adverse Events From Pexa-Vec Administered by IV Infusions or IT Injections in Combination With IV Cemiplimab
Through study completion without survival follow-up period, an average of 1 year · Participants
| Part 1 3 x 10^8 Pfu | 1 Participants |
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| Part 1 1 x 10^9 Pfu | 2 Participants |
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| Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | 8 Participants |
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| Part 2-Arm B, Cemiplimab | 7 Participants |
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| Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | 12 Participants |
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| Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | 13 Participants |
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Overall Response Rate
Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months. · percentage of participants
| Part 1 3 x 10^8 Pfu | 33.3 percentage of participants |
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| Part 1 1 x 10^9 Pfu | 33.3 percentage of participants |
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| Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | 13.3 percentage of participants |
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| Part 2-Arm B, Cemiplimab | 12.5 percentage of participants |
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| Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | 23.3 percentage of participants |
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| Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | 17.9 percentage of participants |
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Number of Participants With Dose Limiting Toxicities of Pexa-Vec Administered by IV Infusions in Combination With Cemiplimab (Part 1 Only)
The 29-day cycle of therapy · participants
| Part 1: 3 x 10^8 Pfu | 0 participants |
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| Part 1: 1 x 10^9 Pfu | 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。