NCT02366195

Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

Detailed description

The study will explore the hypothesis that intratumoral CD8+ cell density at baseline correlates with objective response rate in adults with unresected stage IIIB to IVMIc melanoma treated with talimogene laherparepvec.

Conditions

• Unresected Stage IIIb to IVM1c Melanoma

Interventions

Type	Name	Description
DRUG	Talimogene Laherparepvec	The initial dose of talimogene laherparepvec is up to 4.0 mL of 10\^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10\^8 PFU/mL.

Timeline

• Start date: 2015-04-07
• Primary completion: 2017-06-26
• Completion: 2020-12-25
• First posted: 2015-02-19
• Last updated: 2021-11-30
• Results posted: 2018-07-18

Locations

42 sites across 13 countries: United States, Austria, Belgium, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Russia, Spain, United Kingdom