A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
Phase 1/2
Completed
NCT03294083
| Condition | Renal Cell Carcinoma |
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| Phase | Phase 1/2 |
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| Sponsor | SillaJen, Inc. |
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| Status | Completed |
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| Enrollment | 95 participants |
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| Interventions | Pexastimogene Devacirepvec (Pexa-Vec), Cemiplimab |
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| Start date | Jun 19, 2018 |
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| Completion date | Feb 16, 2023 |
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| Results posted | Jun 18, 2026 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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