Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
TVEC in Cutaneous Squamous Cell Cancer
NCT03714828Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2018
- Primary completion
- Jul 2023
- Countries
- 1
- Sponsor
- University of Arizona
- Modality
- Oncolytic Viruses
- Conditions
- cutaneous squamous cell carcinoma (cSCC)
01
Overview
Phase 2, open-label, single-arm trial of talimogene laherparepvec in cutaneous squamous cell carcinoma (cSCC), sponsored by University of Arizona. Primary endpoint: Overall Response Rate. Started Dec 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (talimogene laherparepvec)
Intralesional injection of TVEC into target lesions.
03
Who it enrols
Immunocompetent adults with at least one histologically confirmed primary low-risk cSCC (including keratoacanthomas) that is unresectable or the patient is unable/unwilling to undergo standard care. Excludes patients with immunosuppression, active herpetic lesions, or prior treatment with TVEC.
04
Endpoints
Primary
Overall Response Rate
Secondary
Number of Participants With Events Requiring the Discontinuation of Study Drug
Time of Response
Duration of Overall Response
Assess Durable Response
Time to Progression
Overall Response Rate by Ultrasound
Overall Clinical Response Rate - Targeted Lesions
Percentage of Participants With Overall Clinical Response Rate - Non-injected Lesion(s)
Beyond the preview
Go deeper on NCT03714828.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03714828.