drugset / Trial / NCT01149343

Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer

NCT01149343 ↗

Phase 1 Completed 107 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this clinical study is to examine the safety, immunogenicity and clinical activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic \[ASCI\]) administered as a first line treatment in patients with unresectable and progressive metastatic cutaneous melanoma.

Timeline

Start
2010-07-02
Primary completion
2014-02-11
Completion
2016-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK2302025A Vaccine 20 ug Intramuscular
Subject GSK2302025A Vaccine 100 ug Intramuscular
Subject GSK2302025A Vaccine 500 ug Intramuscular

Indications