CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Talimogene laherparepvecdrug
Likely dose
Talimogene laherparepvec 4.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02014441
NCT02014441Phase 2Completed
CompareCT.gov

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

Amgen·interventional·Posted Dec 18, 2013·Updated Nov 20, 2019

In Brief

A Phase 2 clinical trial evaluating Talimogene laherparepvec for Melanoma. Completed, enrolled 61 participants across 14 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 18, 2013
Enrollment StartApr 7, 2014
Primary CompletionJan 25, 2016
Study CompletionApr 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.5 years ago

Interventions

Talimogene laherparepvecdrug

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.