Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma — TVEC-325

Unresected Stage IIIb to IVM1c Melanoma Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Melanoma
Unresected Stage IIIb to IVM1c Melanoma

Clinical Trial Details

NCT number	NCT02366195
Study type	Interventional
Source	Amgen
Contact
Status	Completed
Phase	Phase 2
Start date	April 7, 2015
Completion date	December 25, 2020

View Details

See also
	Status	Clinical Trial	Phase
	No longer available	`NCT02147951` - Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma	Phase 3
	No longer available	`NCT02297529` - Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma