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

Melanoma Clinical Trial

Official title:
A Randomized Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC in Patients With Resected MAGE-A3 Positive, Stage IV Melanoma

Clinical Trial 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.

Clinical Trial Description

In the first year, participants may receive up to 8 injections given in the following order:

1. 5 ASCI injections with or without Poly IC:LC with a 3-week interval between each.

2. 3 ASCI injections with or without Poly IC:LC with a 3-month interval between each.

During years 2 through 3, participants may receive up to 5 ASCI injections with or without Poly IC:LC given in the following order:

3. During year 2, ASCI injections with or without Poly IC:LC will be given every 3 months for a total of up to 3 injections.

4. During year 3, ASCI injections with or without Poly IC:LC will continue to be given every 3 months for a total of up to 2 more injections. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01437605
Study type Interventional
Source H. Lee Moffitt Cancer Center and Research Institute
Contact
Status Terminated
Phase Phase 2
Start date October 11, 2011
Completion date July 18, 2018
View Details
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