drugset / Trial / NCT01437605

Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC

NCT01437605

RandomizedParallel-groupOpen-labelTreatment

Summary

The overall purpose of this research study is to find a better way to treat melanoma. The goals of this study are: 1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC 2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with or without the Poly IC:LC 3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC 4. To measure the rate of return of the patient's tumor in two groups of patients: one group positive for the gene signature, and the other group not positive for the gene signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC.

Timeline

Start
2011-10-11
Primary completion
2018-07-18
Completion
2018-07-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator AS15 Other / unclassified
Comparator Hiltonol Other / unclassified
Comparator MAGE-A3 Vaccine

Indications