NCT02014441

Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

A Phase 2, Multicenter, Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec in Subjects With Unresected, Stage IIIB to IVM1c Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after administration of talimogene laherparepvec within the first 3 cycles.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Talimogene laherparepvec	Talimogene laherparepvec will be administered by intralesion injection at an initial dose of up to 4.0 mL of 10\^6 PFU/mL. The second and subsequent doses will will be up to 4.0 mL 10\^8 PFU/mL. The second dose should be administered 21 days from the initial dose. All subsequent doses should be given every 14 days.

Timeline

• Start date: 2014-04-07
• Primary completion: 2016-01-25
• Completion: 2018-04-19
• First posted: 2013-12-18
• Last updated: 2019-11-20
• Results posted: 2017-02-14

Locations

14 sites across 2 countries: United States, Canada