Spots Global Cancer Trial Database for Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT01437605

Conditions

Melanoma

Interventions

MAGE-A3 ASCI injections without Poly IC:LC

MAGE-A3 ASCI injections with Poly IC:LC

Study Description

Brief 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.

Detailed 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.