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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Number of Participants With Adverse Events Related to Study Treatment
Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC
Time frame: Beginning of Treatment to End of Follow Up - up to 5 years per participant
Immunogenicity Per Treatment Arm
Laboratory Endpoint: Assessment of the immunogenicity of the two regimens. Serum antibodies (such as Anti-MAGE-A3) seropositivity status (a seropositive patient is a patient whose titre is greater than or equal to the cut-off value) will be the primary immune endpoints assessed. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2).
Time frame: Beginning of Treatment to End of Follow Up - up to 5 years per participant
Percentage of Participants With Relapse-Free Survival (RFS)
RFS, defined as the time from randomization to the date of first relapse of melanoma or of death, whichever comes first. Percentage of participants with RFS, assessed up to 2 years is reported
Time frame: Beginning of Treatment to End of Follow Up - up to 2 years per participant
Median Overall Survival (OS)
OS defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive will be censored at the date of the last assessment. The primary analysis will be based on the adjusted Cox regression model.
Time frame: At 5 years
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