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An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma

NCT01368276 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-12-18

Study results available
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Summary

The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.

Conditions

Interventions

BIOLOGICAL

Talimogene Laherparepvec

Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection

DRUG

Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)

125 µg/m² subcutaneous injection

Sponsors & Collaborators

  • BioVex Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01368276 on ClinicalTrials.gov