Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-22 @ 7:25 AM
Study NCT ID:
NCT01437605
Status:
TERMINATED
Last Update Posted:
2019-12-20
First Post:
2011-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Treatment Ineffective
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: