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Pexa-Vec and Cemiplimab in Metastatic or Unresectable Renal Cell Carcinoma
NCT03294083Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2018
- Primary completion
- Feb 2023
- Countries
- 3
- Sponsor
- SillaJen
- Modality
- Oncolytic Viruses
- Conditions
- clear cell renal cell carcinoma (ccRCC)
01
Overview
Phase 2, open-label trial of pexastimogene devacirepvec in clear cell renal cell carcinoma (ccRCC) (6 arms), sponsored by SillaJen. Primary endpoints: Adverse Events at 1 year, Overall Response Rate at 36 months and 1 more. Started Jun 2018; status: completed.
02
Design
6 arms- Study design
- Non-randomizedOpen-label
Part 1, Dose escalation 3 x 10^8 pfu
Pexa-Vec IV (3 x 10^8 pfu) + Cemiplimab IV
Part 1, Dose escalation 1 x 10^9 pfu
Pexa-Vec IV (1 x 10^9 pfu) + Cemiplimab IV
Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab
Pexa-Vec IT + Cemiplimab IV
Part 2-Arm B, Cemiplimab
Cemiplimab IV monotherapy, followed by Pexa-Vec IT at progression
Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab
Pexa-Vec IV + Cemiplimab IV
Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab
Pexa-Vec IV + Cemiplimab IV (for patients refractory to prior anti-PD-1/L1)
03
Who it enrols
Patients with metastatic or unresectable clear cell renal cell carcinoma, naive or previously treated, with adequate organ function and Karnofsky PS 70-100. Excludes patients with active autoimmune disease, immunodeficiency, or active Hepatitis B/C.
04
Endpoints
Primary
Adverse Events
Overall Response Rate
Dose Limiting Toxicities
Secondary
Progression-Free Survival
Disease Control Rate
Overall Survival
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