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Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT02366195•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provided informed consent prior to initiation of any study-specific activities/procedures
•2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
•3. Candidate for intralesional therapy
•4. Measurable disease with greatest diameter ≥ 10 mm
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•6. Adequate organ function

Exclusion Criteria

•1. Clinically active cerebral metastases.
•2. Bone metastases
•3. Primary ocular or mucosal melanoma
•4. Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis)
•5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
•6. Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
•7. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception

Locations (42)

Research Site

Salt Lake City, Utah, United States

Research Site

Salzburg, Austria

Research Site

Vienna, Austria

Research Site

Brussels, Belgium

Research Site

Brussels, Belgium

Research Site

Liège, Belgium

Research Site

Boulogne-Billancourt, France

Research Site

Marseille, France

Research Site

Nantes, France

Research Site

Paris, France

Key Dates

Start Date

April 7, 2015

Primary Completion Date

June 26, 2017

Completion Date

December 25, 2020

Last Updated

November 30, 2021

Enrollment

112

ACTUAL participants

Conditions

Unresected Stage IIIb to IVM1c Melanoma

Interventions

Talimogene Laherparepvec

DRUG