drugset / Trial / NCT01266603

High-Dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI

NCT01266603

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2), when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be studied. Researchers will also use samples of the original tumor or metastatic tissue (for example, lymph nodes or liver or lung) that are collected during screening to study if response to the study drug is related to the genes in the tissue.

Timeline

Start
2011-02-22
Primary completion
2018-11-01
Completion
2018-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 720000 iu/kg Intravenous
Subject recMAGE-A3 Protein / enzyme biologic 300 ug Other
Background agatolimod Oligonucleotide (other) 420 ug Other

Indications